Due to their ability to cause the premature shutdown of GE Healthcare’s Carescape R860 ICU ventilators, the U.S. FDA has deemed the company’s recall of more than 100,000 ventilator batteries as a Class 1 event—the most severe kind.
The letter sent by GE in May described a problem with batteries distributed on or after April 1, 2019. Those batteries may fail earlier than their estimated life and “the alarm that alerts the user on battery run time remaining could potentially be inaccurate,” the company said. A battery that runs out earlier than expected could shut down a ventilator and stop the supply of oxygen to the patient with life-threatening consequences.
At the time of writing the urgent field safety notice, GE had received no reports of injuries as a result of the issue. Still, the potential for the fault to cause serious injuries or death led the FDA to categorize the recall as a Class I event.
Read the full article on MedTechDive.