35X ProFlexx® 0015710Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00190790000332), received between Nov 29, 2016 and Dec 19, 2024 — classified as 1 death, 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THE STRETCHER ALLEGEDLY FAILED TO ENGAGE WITH THE AMBULANCE SAFETY HOOK AND THE PATIENT FELL OFF THE STRETCHER RESULTING IN AN ABRASION TO THEIR HEAD AND LEFT ARM. THE PATIENT WAS TRANSPORTED TO THE ER FOR FURTHER EVALUATION. NO FURTHER DETAILS OF THE INCIDENT WERE PROVIDED.

  Patient problems: Abrasion

  MAUDE report 20976590 ↗
• InjuryMar 23, 2020Unintended Movement; Unintended Movement

  THE COMPLAINANT ALLEGES WHILE UNLOADING THE COT FROM THE AMBULANCE, THE COT LEGS ALLEGEDLY FAILED TO LOWER. THE STRETCHER TILTED TO THE SIDE RESULTING IN AN ALLEGED INJURY TO A MEDIC. NO DETAILS WERE PROVIDED PERTAINING TO THE NATURE OF THE INJURY OR MEDICAL INTERVENTION SOUGHT.

  Patient problems: Injury

  MAUDE report 9869189 ↗
• MalfunctionJan 30, 2020Unintended Movement; Unintended Movement

  THE COMPLAINANT REPORTED WHILE TRANSPORTING A PATIENT ON THE COT WHICH WAS LOCKED IN THE FASTENING DEVICE, THE COT ALLEGEDLY BECAME DISLODGED ALLOWING THE COT TO STRIKE THE MEDIC'S BENCH SEAT. THE PATIENT ALLEGED INJURY, BUT NO FURTHER DETAILS HAVE BEEN PROVIDED PERTAINING TO THE ALLEGED INJURY AND/OR MEDICAL INTERVENTION SOUGHT.

  Patient problems: Injury

  MAUDE report 9649415 ↗
• InjuryMay 22, 2019Unintended Movement; Unintended Collision; Device Tipped Over; Unintended Movement

  THE COMPLAINANT REPORTED WHILE UNLOADING A PATIENT FROM THE AMBULANCE, THE LEGS OF THE STRETCHER STRUCK THE REAR BUMPER AND DID NOT LOWER COMPLETELY. THE STRETCHER THEN ALLEGEDLY MISSED THE SAFETY HOOK AND TIPPED TO THE RIGHT LANDING ON ITS RIGHT SIDE. THE PATIENT REPORTED RIGHT ARM AND RIB PAIN. DETAILS OF THE INJURY AND MEDICAL TREATMENT WERE NOT PROVIDED.

  Patient problems: Pain

  MAUDE report 8632600 ↗
• DeathMay 29, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED WHILE LOADING A PATIENT ONTO THE COT, THE MATTRESS ALLEGEDLY SLID AND THE PATIENT SLID TO THE GROUND.. THE PATIENT WAS PLACED BACK ONTO THE COT WITHOUT FURTHER INCIDENT. THE COT WAS APPROXIMATELY AT MID THIGH LEVEL WHEN THE PATIENT WAS BEING LOADED. IT WAS STATED THE PATIENT PASSED AWAY; HOWEVER, THE PATIENT'S CONDITION PRIOR TO THE ALLEGED INCIDENT WAS REPORTED AS TRAUMATIC CARDIAC ARREST.

  Patient problems: Cardiac Arrest; Death; Fall

  MAUDE report 7548560 ↗
• InjuryDec 13, 2017Device Tipped Over; Malposition of Device; Device Tipped Over

  THE COMPLAINANT REPORTED WHILE ATTEMPTING TO LOAD A PATIENT, THE PATIENT SHIFTED THEIR WEIGHT CAUSING THE STRETCHER TO ALLEGEDLY TIP TO THE RIGHT SIDE. IT WAS REPORTED THE PATIENT REMAINED ON THE STRETCHER AND NEVER MADE CONTACT WITH THE GROUND. THE PATIENT COMPLAINED OF KNEE PAIN ALLEGED FROM PRESSURE AGAINST THE RESTRAINT. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Pain

  MAUDE report 7113017 ↗
• InjuryApr 19, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED WHILE REMOVING A PATIENT FROM THE AMBULANCE THE UNDERCARRIAGE OF THE COT WOULD ALLEGEDLY NOT LOWER. WHILE TRYING TO LOWER THE UNDERCARRIAGE, THE PATIENT'S WEIGHT SHIFTED CAUSING THE COT TO TIP OVER ONTO THE GROUND. THE PATIENT CLAIMED NO INJURY AFTER THE INCIDENT. BOTH CREW MEMBERS ALLEGED INJURY TO THEIR LOWER BACK AND LEGS AND WERE SEEN AT THE ER. NO FURTHER DETAILS OF THE INCIDENT OR ALLEGED INJURIES HAVE BEEN RECEIVED.

  Patient problems: Fall; Injury

  MAUDE report 6502984 ↗
• InjuryApr 3, 2017Difficult to Open or Close; Mechanical Jam; Positioning Problem; Positioning Problem

  IT WAS REPORTED WHILE LOADING THE COT INTO THE AMBULANCE THE LEGS OF THE COT ALLEGEDLY BECAME LOCKED AND WERE UNABLE TO BE LIFTED. THERE WERE NO REPORTS OF A DELAY IN TRANSFER OR INJURY TO THE PATIENT; HOWEVER, A MEDIC HAS ALLEGED A FOREARM INJURY AS A RESULT OF THE INCIDENT. THE INITIAL REPORT STATES THE MEDIC SOUGHT TREATMENT IN THE ER; HOWEVER, NO DETAILS OF THE NATURE OF THE TREATMENT OR THE SEVERITY OF THE ALLEGED INJURY WERE PROVIDED.

  Patient problems: Injury

  MAUDE report 6452984 ↗
• MalfunctionMar 10, 2017Device Tipped Over

  IT WAS REPORTED WHILE ON SCENE THE CREW WAS LIFTING THE STRETCHER TO THE TOP LEVEL TO DROP THE DRAG WHEELS SO THE STRETCHER WOULD FIT INTO THE ELEVATOR. THE CREW ALLEGES THE PATIENT SHIFTED THEIR WEIGHT CAUSING THE STRETCHER TO TIP OVER. NO FURTHER DETAILS HAVE BEEN PROVIDED BY THE COMPLAINANT REGARDING THE ALLEGED INCIDENT OR THE IMPACT TO THE PATIENT.

  Patient problems: No Information

  MAUDE report 6395228 ↗
• Jan 3, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THE COT AND PATIENT WERE UNLOADED FROM AN AMBULANCE AND WHEN THE LEGS OF THE COT WERE RELEASED DOWN, UPON FURTHER EXIT, THE COT ALLEGEDLY COLLAPSED CAUSING THE COT TO STRIKE THE EMT IN BOTH OF HIS LEGS. THE PATIENT WAS NOT INJURED; HOWEVER, THE PROVIDED INCIDENT REPORT INDICATED THE MEDIC SOUGHT MEDICAL TREATMENT AT THE ER. NO DETAILS WERE PROVIDED REGARDING THE ALLEGED INJURY OR THE REQUIRED MEDICAL TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6220149 ↗
• Nov 29, 2016Device Tipped Over; Device Operates Differently Than Expected; Unintended Movement

  IT WAS REPORTED AFTER REMOVING THE PATIENT AND COT FROM THE AMBULANCE THE CREW ENGAGED THE STRETCHER LOCK AND THEN STEPPED AWAY FROM THE COT TO TURN THE AMBULANCE OFF. THE STRETCHER LOCK ALLEGEDLY DISENGAGED AND THE STRETCHER BEGAN TO ROLL. THE EMT ATTEMPTED TO CONTROL THE STRETCHER BUT DUE TO THE PATIENT'S WEIGHT WAS UNABLE TO HOLD THE STRETCHER AND IT TIPPED OVER WITH THE PATIENT. THE PATIENT WAS ASSESSED AND ALLEGEDLY COMPLAINED OF PAIN TO HER LEFT SHOULDER. THE CREW TRANSPORTED THE PATIENT INTO THE HOSPITAL AND ALERTED THE RECEIVING RN TO THE INCIDENT AND ALLEGATION OF PAIN.

  Patient problems: Fall; Pain

  MAUDE report 6132487 ↗