In June 2021, Philips Respironics recalled some of their V60 and V60 Plus ventilators that were equipped with high flow therapy software versions 3.00 and 3.10 due to the risk of receiving reduced oxygen. V60 and V60 Plus ventilators provide high-flow oxygen therapy and noninvasive ventilation to patients in healthcare facilities. The U.S. Food and Drug Administration (FDA) classified the recall as Class 1 which is the most serious type of recall due to the potential for serious complications that include death.
The recall came after 25 injuries linked to the devices were reported. The recall was triggered by identifying the risk that the ventilators that had been upgraded to enable high flow therapy may actually provide the patient with a lower oxygen flow rate. Decreasing the flow rate can cause oxygen desaturation, respiratory distress, and clinical deterioration. This recall covered 16,635 devices distributed in the United States between May 2009 and June 2021.
Philips Respironics started 2022 with a new ventilator recall due to expired adhesive. The adhesive material holds the parts of the device together and it could be dangerous if the parts become loose. Complications from the expired adhesive could cause the ventilator to stop working with or without an alarm due to damage to internal capacitors. This recall impacted 1,511 devices that were distributed in the United States from July 29, 2021, through August 11, 2021.
In March 2022, Philips Respironics updated the January 2022 ventilator recall to include all V60, V60 Plus, and V680 ventilators. Although the V680 ventilators are not distributed in the United States, more than 56,000 V60 and V60 Plus devices that were distributed in the United States were impacted. These devices were distributed between May 2009 and December 2021.
The increased recall stemmed from an issue with the ventilator’s internal power mechanism. Internal energy fluctuations could cause a complete shutdown of the ventilator with or without a warning which can leave patients deprived of vital oxygen.
The ventilator recalls escalated in April 2022 after Philips Respironics received four injury reports and one death report from the recalled devices’ power fluctuations. In response, Philips Respironics issued another recall of all V60, V60 Plus, and V680 ventilators.
Since problems with the ventilators’ internal power fluctuation could cause the ventilator to shut down with or without warning and leave patients without oxygen, the FDA classified the recall as Class 1 due to the potential for serious consequences that could lead to death.
How GoldenbergLaw Can Help You
If you or a loved one were harmed by your V60 or V60 Plus ventilator shutting down, contact the Medical Device Attorneys at GoldenbergLaw. Our team understands the complexities of medical device lawsuits, and we want to help you. Our team has provided the Gold Standard of advocacy to our clients for more than 35 years today. Contact us today to see how we can help you!