The reported issue involves three freedom drivers and are reported under three separate medical device reports: freedom driver sn (b)(4) (mfr report # 3003761017-2015-00067); freedom driver sn (b)(4) (mfr report # 3003761017-2015-00068); and freedom driver sn (b)(4) (mfr report # 3003761017-2015-00069).The customer reported that all three freedom drivers exhibited fault alarms while supporting a pt at home.The customer also reported that the pt, who was at home, was unconscious with labored breathing when the first driver exhibited a fault alarm.The pt was transported to the emergency room at (b)(6) and switched to the second freedom driver.The second freedom driver exhibited a fault alarm and the pt was switched to the third freedom driver.Third freedom driver exhibited a fault alarm.The pt subsequently expired.
|