Lately, there has been a surge in ventilator recalls implicating a variety of ventilators and ventilator components. If you or a loved one have been injured by a recalled ventilator, let GoldenbergLaw help you hold the manufacturer accountable. Patients use ventilators in their most vulnerable moments, and you should be able to trust that the device is safe.
Ventilators keep people alive. These devices are life-saving and life-sustaining. They are also extremely complex and have a lot of parts that all need to work properly for the device to do its critical work. When the entire ventilator or even a component of the ventilator does not work properly, a patient’s life could be in danger.
Volara System Recall
In April 2022, Baxter Healthcare Corporation and its subsidiary, Hillrom, recalled the Volara system due to the risk of respiratory distress. The U.S. Food and Drug Administration (FDA) labeled the recall as Class 1 which is the most severe because the use of the recalled product could cause serious injuries or death. The specific recalled product is the Volara system with an in-line ventilator adaptor (OPTIMUS Handset 2) or Volara patient circuit kit (OPTIMUS OLE AC Patient Circuit Kit). The devices were distributed from May 28, 2020, through April 2022. In total, 268 devices were recalled in the United States.
The Volara system is supposed to help people clear mucus out of their airways, expand their lungs, and treat or prevent partially collapsed lungs, known as pulmonary atelectasis. The system’s in-line ventilator adaptor component makes it possible to use the system with an in-line ventilator at home.
The Volara system was recalled because the in-line ventilator adaptor may prevent patients from getting enough oxygen from the ventilator as a result of overexpansion of the lungs leading to a subsequent drop in oxygen levels. Risks to patients include choking on mucus or other airway secretions, infections in the lungs (pneumonia) that prevent oxygen from getting to the brain (respiratory failure), brain injury due to lack of oxygen to the brain (hypoxia), and death. The risk of serious injury or death is more significant in home-care settings if caregivers are not trained properly, the device is not connected properly, or the caregiver is not prepared to address any issues that may arise caused by the use of the device. At this time, one complaint, one injury, and two deaths were reported.
Philips Respironics V60, V60 Plus, and V680 Ventilator Recall
The Philips Respironics (Philips) ventilator recalls have escalated since the original V60 and V60 plus ventilator recall in June 2021. The first recall of V60 and V60 Plus ventilators that are equipped with high-flow therapy software versions 3.00 and 3.10 actually caused a risk that patients would receive reduced oxygen. This could cause oxygen desaturation, respiratory distress, and clinical deterioration. In response to 25 injuries linked to the device, Philips issued the recall and the FDA classified it as Class 1. The recall covered 16,635 devices in the United States that were distributed between May 20089 and June 2021.
In January 2022, Philips added a new recall due to expired adhesive materials that were being used to hold parts of the device together. It could be dangerous for patients if parts become loose. Complications could cause the ventilator to stop working with or without an alarm alerting the patient or their caregivers. This recall impacted 1,511 devices that were distributed in the U.S. between July 29, 2021, and August 11, 2021.
The March and April 2022 recalls were related to the devices’ internal power mechanism and included all V60, V60 Plus, and V680 ventilators. Although the V680 ventilators are not distributed in the U.S., more than 56,000 V60 and V60 Plus ventilators in the U.S.were impacted by the recall. Internal energy fluctuations in the device could cause a complete shutdown of the ventilator with or without a warning which could leave patients deprived of oxygen. The recall escalated in April 2022 after Philips received 4 injury reports and one death report due to the internal power issue. The FDA also classified this recall as Class 1 due to the potential for serious injury and death.
Draeger, Inc.’s SafeStar 55 Breathing System Recall
In May 2022, Draeger, Inc. recalled one lot of defective SafeStar breathing system filters because the defect could cause an obstruction that blocks the flow of oxygen to patients. The lot number is LT2103 and impacts 35,950 devices in the United States. The devices were distributed from August 18, 2021, through October 12, 2021.
The breathing system filter is part of a ventilator system when a patient is under anesthesia or needs breathing assistance. It’s supposed to reduce the number of bacteria, micro-organisms, and small particles that could reach the patient. However, the company discovered that the filters were damaged during the manual inspection process. They were supposed to be destroyed; however, they were placed in devices. The defective breathing filter could cause the breathing system to become obstructed which could cause a reduced amount of oxygen being provided to the patient. The lack of oxygen (hypoxia) could cause serious injuries including death. At this time, one complaint and one injury were reported.
GE Healthcare’s Ventilator Battery Recall
In April 2022, GE Healthcare recalled more than 100,000 ventilator batteries due to their potential to cause a premature shutdown of the ventilator. Although no injuries or deaths have been reported yet, the FDA classified the recall as Class 1 because a battery that runs out earlier than expected could cause the ventilator to unexpectedly shut down which would stop the flow of oxygen to the patient. This oxygen deprivation on a ventilator-dependent patient could cause life-threatening consequences.
The April 2022 recall covers specific backup batteries and replacement backup batteries for 29, 417 backup batteries for the Carescape R860 and 88,347 replacement batteries for the Carescape R860, Engström Carestation, and Engström PRO ventilators that were distributed on or after April 1, 2019. The batteries were recalled because the affected batteries can fail before their estimated shut down timeframe and the alarm that alerts the user about the battery run time remaining could be inaccurate. As a result, the ventilator may shut down prematurely when they are not connected to the AC main power supply and deprive the patient of the oxygen they need to survive. Oxygen deprivation could cause serious injuries and even death.
GE Healthcare told users to keep their ventilators plugged into the main AC power source whenever possible. However, if it’s “absolutely necessary” to switch to battery power, there should be a readily accessible means of alternative ventilation ready.