What Patients Need to Know About the new Hamilton Medical and Philips Respironics FDA Ventilator Recalls
The U.S. Food and Drug Administration (FDA) has issued warning to the public this week by issuing two Class I recallsfor ventilation products manufactured by Hamilton Medical and Philips Respironics. Both recalls are a testament to the fact that medical devices, despite their life-saving potential, can sometimes have dangerous flaws that compromise patient safety.
Hamilton Medical’s Ventilator Recall
The FDA’s announcement reveals that three models of Hamilton Medical ventilators – namely the Hamilton-C1, Hamilton-T1, and Hamilton-MR1 – have been recalled due to safety risks. The primary concern stems from a potential electrolyte fluid leakage from the capacitors, posing a risk of the device’s control board short-circuiting. Such a malfunction could inadvertently trigger the “Ambient State” message on the display.
When clinicians encounter this “Ambient State” message, they must switch to alternative ventilation means, like using a manual resuscitating device or transitioning the patient to another ventilator altogether. It’s crucial to note that the recall involves 1,468 devices circulated between July 28, 2020, and August 8, 2020. Thankfully, the FDA has confirmed no incidents or casualties resulting from this flaw. On July 26, 2023, Hamilton Medical communicated with its users via an Urgent Medical Device Correction letter, directing them to solicit service for any device exhibiting the “Ambient State” indication.
Philips Respironics Ventilator Recall
Meanwhile, Philips Respironics has faced recall action for its V60 Ventilators and V60 Plus Ventilators, tailored for both pediatric and adult patients. The core issue lies in the power management printed circuit board assemblies, which fall short of meeting ventilator standards due to distribution through a third-party warehouse.
It’s paramount for caregivers and patients to understand that any lapses in direct monitoring of those using these Philips ventilators may elevate the risk of adverse outcomes. The potential threats range from mere power failure to severe ventilator malfunction and, in the worst-case scenario, death. This recall covers eight units distributed exclusively on May 6, 2023. Philips Respironics confirmed no reported injuries or fatalities related to this issue and urged its users in an August 2023 letter to cease the device’s usage until further guidance.
Compensation for Harmed Caused By Defective Ventilators
Victims who’ve experienced medical complications due to these recalled ventilators may have legal recourse. A lawsuit can be initiated to seek damages for damages, be it physical, emotional, and/or financial. The potential damages might include medical bills, pain and suffering, lost wages, and more.
The lawsuit process begins with the filing of a complaint, followed by the discovery phase, where both sides gather evidence. A trial will ensue if no settlement is reached. Each stage requires the expert knowledge and skills of an attorney specializing in product liability, as they can navigate the intricacies, negotiate settlements, and ensure victims receive fair compensation.
Why Choose Parker Waichman LLP?
For those harmed by this recalled medical devise, turning to an experienced law firm like Parker Waichman LLP can be invaluable. The firm’s experience in product liability lawsuits makes sure that victims have a fighting chance against powerful medical device manufacturers. Don’t navigate this challenging time alone. For your free consultation, contact Parker Waichman LLP at 1-800-YOUR-LAWYER (1-800-968-7529).
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