Servo-i Ventilator Recall Issued Due to Short Battery Life
Roughly 90,000 ventilator battery modules may have a shorter run time than anticipated, posing a risk that the ventilator may shutdown suddenly and cause serious, or even fatal, consequences for users.
A Maquet SERVO-I Ventilator battery module recall was announced by the FDA on March 7, after the manufacturer learned the battery life for the SERVO-I ventilators may shutdown during use, even though the battery life displays sufficient charge.
The recalled battery modules for the Maquet SERVO-I ventilator systems are used to power the ventilator during intra-hospital transportation and to monitor patients with respiratory failure or insufficiency. If the battery fails and causes the ventilator to shut down for patients with severe conditions, it may cause suffocation and possibly death.
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The recalled battery modules were manufactured by Maquet Cardiovascular US Sales, LLC, of Wayne New Jersey and were distributed throughout the United States from February 15, 2010 to November 19, 2012.
Maquet Cardiovascular sent its customers a Field Safety Notice on March 7, with instructions to change the power source to AC and to replace the battery modules if the display screen shows a “low battery voltage” or “replace battery” message. The letter also outlines how to complete and send back a Field Safety Notice Confirmation Form by email at FieldAction@maquet.com or by fax at (873) 807-1832.
Federal health officials have categorized this action as a Class I medical device recall, indicating there is a probability that the use of this product may cause serious or adverse health consequences including death.
A similar medical battery recall occurred last month when the FDA announced a Hospira Gemstar Infusion System recall due to a risk that the lithium battery in the infusion systems may malfunction if the voltage level drops below 2.4 volts and cause delay or interrupt therapy sessions possibly creating life-threatening injuries to the patient.
Consumers are encouraged to follow the battery source and replacement instructions and to call Maquet Customer Service at 888-627-8383 or email them at FieldAction@maquet.com for further question and detail.
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