According to a news report on medtechdive.com, the U.S. Food and Drug Administration has classified G.E. Healthcare’s ventilator battery recall as a Class I event. A Class I recall was initiated because the ventilator batteries can cause a “premature shutdown of the device.” If a ventilator shuts down, the patient could suffer severe injury or death. The recall involves certain G.E.’s Carescape R860 ICU ventilator backup and replacement batteries. The affected batteries might not provide enough power to the ventilators when the ventilators are not connected to an A.C. power supply.
G.E. Healthcare advises clinical sites with the recalled ventilators batteries to keep their ventilators connected to their main A.C. power supply when possible. When it is “absolutely necessary” to change to battery power, clinicians should keep alternative ventilation equipment ready. The report states that there haven’t been any patient injuries or deaths reported. G.E. Healthcare reported in an emailed statement that no devices or device parts need to be retrieved during the recall.
A G.E. Healthcare letter in May describes the recalled batteries that were distributed on or after April 1, 2019. The recall announcement states that the affected batteries can fail before their estimated life, and the battery run time alarm could be inaccurate. The issue can stop the supply of oxygen to the patient causing life-threatening outcomes.
The G.E.’s Carescape R860 ICU ventilator battery recall includes more than 29,000 Carescape R860 backup batteries and over 88,000 replacement backup batteries for the Engström Carestation, Carescape R860, and Engström PRO ventilators.
G.E. is asking medical sites that have batteries affected by the recall to conduct a performance test. This test involves:
- Fully charging the batteries for at least eight hours.
- Disconnecting the power cord.
- Powering the ventilator for 60 minutes or longer.
Batteries that fail prior to 60 minutes must be replaced. G.E. is asking medical sites to record shut down time on a form provided by G.E. G.E. is also asking medical sites to run the battery performance test quarterly and to run the test prior to use. The backup batteries should be replaced every three years.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Were you or a loved one harmed by a defective product? Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous product. For your free consultation, contact our law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
New York | Brooklyn | Queens | Long Island | New Jersey | Florida
Call us at: 1-800-YOURLAWYER (800-968-7529) | Schedule your free consultation