GE Healthcare’s Ventilator Battery Recall Obtains FDA Class I Label Due to Risk of Device Shutdown


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Diving brief:

  • The Food and Drug Administration categorized GE Healthcare recalled over 100,000 ventilator batteries as a Class I event due to their potential to cause premature device shutdown.
  • The recall covers certain backup batteries and replacement backup batteries for GE’s Carescape R860 ICU ventilators. Since batteries may not provide sufficient backup power, fans may stop prematurely when not connected to main AC power.
  • GE Healthcare, which alerted users to the issue in April, advises sites with the affected batteries to keep their ventilators on main power whenever possible. If it is “absolutely necessary” to switch to battery power, sites should have an easily accessible means of alternative ventilation, he added. No patient injuries or deaths have been reported as a result of this issue, GE Healthcare said in an emailed statement. The company added that no devices or parts will need to be recovered as part of the recall.

Overview of the dive:

The letter sent by GE in May describes an issue with batteries distributed on or after April 1, 2019. These batteries can fail sooner than their estimated lifespan, and “the alarm that alerts the user to remaining battery run time could potentially be inaccurate,” the company said. A battery that runs out sooner than expected could shut down a ventilator and cut off the patient’s oxygen supply with life-threatening consequences.

At the time of writing the Urgent Field Safety Notice, GE had not received any injury reports as a result of the issue. Still, the possibility of the fault causing serious injury or death led the FDA to classify the recall as a Class I event.

The reminder includes 29,417 backup batteries for Carescape R860 and 88,347 replacement backup batteries for the Carescape R860, Engstrom Care station and Engstrom PRO.

According to the company, in 10 cases the Carescape R860 ventilator stopped due to the problem while being used on backup batteries, but in all cases alternative means of ventilation were used and no cases of harm to the patient has been reported.

GE wants sites whose batteries are covered by the recall to perform a performance test. The test involves fully charging the batteries by connecting the ventilator to the main power source for at least eight hours. Once charged, the user must connect a patient circuit and test lung to the ventilator, set the parameters chosen by GE, start ventilation, and unplug the power cord from the mains. If the batteries power the ventilator for 60 minutes or more, they have sufficient charge, according to the company.

Sites whose batteries fail before 60 minutes should contact their authorized service representative for replacements, GE added. The company asks sites to record the closing time on the form it will provide. GE requires sites to perform the battery performance test every three months. If a battery is stored for more than three months, the site should perform the test before using the device, he said, adding that backup batteries should be replaced at least every three years.

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