PowerFlexx® 0015654Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190790000189), received between Oct 5, 2016 and Feb 21, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2017Detachment Of Device Component; Unintended Movement

  IT WAS REPORTED AN AMBULANCE WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT WHERE IT WAS IMPACTED ON THE PASSENGER SIDE BY ANOTHER VEHICLE TRAVELING ABOUT 35 MPH. IT IS ALLEGED AT THE TIME OF IMPACT THE COT RELEASED FROM THE ANTLER AND THE COT SHIFTED TO THE PATIENT'S RIGHT SIDE AND THE PATIENT STRUCK THEIR HEAD ON A CABINET CAUSING A LACERATION. THE PATIENT REMAINED SECURED ON THE COT THROUGHOUT THE ACCIDENT. THE PATIENT WAS TREATED FOR THE LACERATION AND ANOTHER MEDIC WAS CALLED TO CONTINUE THE TRANSPORT OF THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED ON THE PATIENT. AN INVESTIGATION OF THIS INCIDENT HAS BEEN INITIATED.

  Patient problems: Laceration(s)

  MAUDE report 6345486 ↗
• Oct 5, 2016Unintended Movement; Unintended System Motion; Device Inoperable; Unintended Movement

  IT WAS REPORTED WHILE ONSITE FOR A NON-EMERGENCY BARIATRIC PATIENT TRANSPORT THE COT WOULD ALLEGEDLY NOT WORK IN POWER MODE. THE CREW REPLACED THE POWERPAC WITH AN EXTRA PAC THEY HAD WITH THEM. WHILE BOTH MEDICS WERE REACHING UNDER THE COT TO CONNECT THE NEW POWERPAC, THE COT ALLEGEDLY LOWERED APPROX 6 INCHES TRAPPING THEIR ARMS BENEATH THE COT. IT WAS ALSO REPORTED THE COT THEN LOWERED AN ADDITIONAL 6 INCHES. THE MANUAL RELEASE WAS USED TO RAISE THE COT TO ALLOW THE MEDICS TO REMOVE THEIR ARMS. THE PATIENT HAD NOT BEEN LOADED ONTO THE COT AT THE TIME OF INCIDENT AND ANOTHER SERVICE WAS CALLED TO COMPLETE THE TRANSPORT. THE MEDICS DID SEEK MEDICAL INTERVENTION AS A RESULT OF THE INCIDENT AND IT WAS REPORTED THE MEDICS RECEIVED BRUISING TO THE FOREARMS. THE MEDICS WERE OFF WORK FOR APPROXIMATELY 3 DAYS AND HAVE SINCE RETURNED TO THEIR PREVIOUS POSITIONS. AN INVESTIGATION WILL BE INITIATED TO EVALUATE THE REPORTED INCIDENT.

  Patient problems: Bruise/Contusion; Physical Entrapment

  MAUDE report 6001049 ↗