defective medical device

Published on: September 28, 2023

Philips Respironics Recall: New Investigation Reveals Blatant Corporate Negligence

In a startling revelation brought to light by the investigative efforts of ProPublica and the Pittsburgh Post-Gazette, the Philips Respironics case has unveiled a disturbing narrative of corporate negligence. Over an 11-year period, this medical device manufacturer concealed mounting evidence of serious issues with its breathing machines, placing profit above patient safety.

In 2010, Philips Respironics, a renowned manufacturer of breathing machines used globally in homes and hospitals, made a pivotal decision to redesign its best-selling devices. The intention was to eliminate an annoying rattle that kept users awake at night. However, this seemingly well-intentioned decision led to a cascade of problems that has left countless individuals in distress and brought the company under intense scrutiny.

To dampen the irritating noise issue, Philips opted for an industrial foam, akin to what you might find in your sofa or mattress. Little did they know that this choice would prove catastrophic. Reports began to emerge, describing “black particles,” “dirt and dust,” and even an “oily-like” substance within the breathing machines. Users were sounding the alarm about “contamination,” signaling that something was seriously amiss.

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Published on: June 14, 2023

Product Liability and Patient Safety: The Philips Evo Ventilator Recall

By GGCRBHS&M

Recent recalls by Philips have highlighted the importance of product liability and patient safety in the healthcare sector. The latest recall involves approximately 57,000 Evo ventilators due to issues with the machines’ air flow sensors.

Philips’ Respironics unit has faced a series of recalls since 2021, initially related to soundproofing foam used in its sleep apnea devices and ventilators. The Evo ventilator, designed for hospital and professional care settings, is now undergoing its second Class I recall in recent months. The recent recall, labeled as Class I by the U.S. Food and Drug Administration (FDA), highlights the severity of the issue.

Reasons for Recall

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Published on: October 21, 2021

The recent recall of defective Philipps sleep apnea ventilator devices demonstrates the inhability of the FDA at managing medical device recall

By GGCRBHS&M

After a recent study pointed fingers at the mismanagement of medical device recall by the FDA (see previous blog), further investigations are confirming an outdated and broken system that leaves patients at risk of serious injury and death as unaware doctors continue to use defective devices on their patients.

A recent example of this outdated process is the recall of a sleep apnea ventilator device manufactured by Philips. It is not clear so far as to when exactly, Philips executives found out that the foam used to dampen the noise of the machine was breaking down and could potentially be inhaled or ingested by patients, exposing them to carcinogenic or toxic effects. However, the company announced publicly, on April 26th, while reporting Q1 earnings that it was creating a provision of 250 million Euros to cover costs related to possible risks to users in some sleep and respiratory care machines. While the company had probably already identified that the defective devices were the ones manufactured between April 2007 and April 2021, it waited almost two other months to initiate a recall and warn consumers of potential carcinogenic and toxic effects. After the issuance of the recall, the FDA issued a safety communication on June 30. It took until July 22nd for the FDA to classify the recall as class I event and publish a public notification.

Does this mean that all patients have been contacted and had their ventilator changed? Not at all. In the actual process, the customers of the manufacturer, such as the hospitals, the providers, the retailers or the distributors are in charged of contacting the patients and they usually don’t do it. Instead, doctors wait for the patients to come in with symptoms.

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Published on: August 10, 2021

HeartWare Ventricular Assist Device implanted in patients despite FDA knowledge of product being defective

By GGCRBHS&M

Medtronic stopped the sale of the defective HeartWare Ventricular Assist Device, or HVAD last June after more than 3,000 patients died and 20,000 were injured.

Since 2011, multiple problems with the device have been reported to the Food and Drug Administration but the agency never took any decisive action to make sure the manufacturer fixed the problems. The FDA and its Center for Devices and Radiological Health are in charge of making sure that medical devices are safe and effective for patients however as we highlighted in a previous blog, the agency policy is too accommodating with manufacturers. It has the power to seize products or to issue fines but rarely uses it.

In the case of the HeartWare Ventricular Assist Device, the FDA knew about issues with the product as early as 2011 when the product was developed by the parent company HeartWare and was seeking FDA approval. An inspector mentioned in its report that engineers were not reviewing documents fully before approving them and that the employee assigned to quality control did not have sufficient training. The company told the FDA they would take corrective actions.

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Published on: May 8, 2015

51 reports of personal injuries and one death prompt the FDA to announce an urgent Class I Recall of Maquet’s Tiger Paw System II, a medical device used during heart surgery

By GGCRBHS&M

A defective surgical staple used to close tissue in the left atrial appendage of the heart is being recalled by the FDA after reports that patients suffered personal injuries such as tissue tears and bleeding including a possible tear of the left atrial wall (top left chamber) during use of the device. The manufacturer of the defective medical device, Maquet Medical Systems, sent an “Urgent Medical Device Recall (Removal) Immediate Action Required” letter to all affected customers asking them to immediately remove and quarantine the Tiger paw System II from their inventory.

Read the press release from the FDA

Published on: March 5, 2015

With the first product liability lawsuits being filed against duodenoscope manufacturers, it was diclosed today that the devices that led to the CRE outbreak at UCLA where not FDA approved

By GGCRBHS&M

Patients and family of patients that have been infected by contaminated duodenoscopes at UCLA Hospital started to file product liability lawsuits against Olympus, the manufacturer of the medical devices. 18 year old Aaron Young was the first one to file his lawsuit. The high school student is still hospitalized and receiving treatment for carbapenem-resistant Enterobacteriaceae (CRE), a bacteria highly resistant to antibiotics that can kill up to 50% of patients infected. The family of Antonia Cerda who died in the same hospital after contracting the “superbug” also filed a lawsuit against Olympus for wrongful death, alleged negligence and fraud. Antnonia Cerda was 48 year old and the mother of 4 children. Both lawsuits have not yet named UCLA as the hospital said the cleaning protocol provided by Olympus was applied.

Today CNN announced that the duodenoscopes used in the procedures that spread the superbug were indeed not approved by the FDA. Olympus started to sell the TJF-Q180V duodenoscope in 2010 without asking for clearance and the FDA did not become aware until the end of 2013 or beginning of 2014. Olympus said it didn’t think it needed the FDA’s permission to sell the device, but now at the request of the agency, it has applied for that permission. That application is still pending. Read more on the CNN website

Published on: January 28, 2015

To prevent personal injury or death related to defective automated external defibrillators, the FDA just announced that manufacturers will now be required to submit premarket approval applications for their new products

By GGCRBHS&M

When a person is injured or dies because of an automated external defibrillator failure, it is often the result of a defective design or a manufacturing flaw such as the inadequate quality control of outsourced components. Automated External Defibrillators (AEDs) are usually stored in public places and ready for use if someone suddenly suffers from a life threatening cardiac arrhythmia. Unfortunately these medical devices have a history of malfunctions. In the last 10 years the FDA received more than 72,000 medical reports associated with defective AEDs. During the same period of time, 111 recalls were conducted affecting more than two million defective products.

Therefore the FDA decided to take additional steps to improve the quality of these products. The agency issued a final order that will require AED manufacturers to submit premarket approval applications (PMAs), which undergo a more rigorous review than what was required to market these products in the past.

Read the FDA press release here

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Published on: October 20, 2013

Product Liability – Defective Medical Device: FDA initiates Class 1 recall of some Bard LifeStent Solo Vascular Stents because they may fail to deploy

By GGCRBHS&M

defective%20stent.jpg The defective stents may cause serious personal injury such as complications of bleeding, loss of limb, heart attack (myocardial infarction), stroke, vascular surgery, and/or death if they fail to deploy properly.

The LifeStent Solo Vascular Stent manufactured by Bard Peripheral Vascular is an implantable self-expanding stent and delivery system used to improve the inner open space of a blood vessel in patients who have lesions caused by abnormal narrowing of the affected blood vessel.

Defective products were manufactured and distributed from November 2011 to June 13, 2012 , the defective implants code information can be found on the FDA website