M1 6100 (REF 6100-031-000)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327261561), received between Oct 1, 2018 and Oct 27, 2025 — classified as 1 death, 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Protective Measures Problem; Protective Measures Problem

  NO NEW INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393205 ↗
• DeathSep 6, 2023Device Tipped Over; Device Tipped Over

  IT WAS REPORTED THAT A STAFF MEMBER WAS MANEUVERING THE COT BY THEMSELVES WITH A PATIENT ONBOARD AND THE COT TIPPED RESULTING IN PATIENT DEATH. THE CUSTOMER STATED THAT THE TIP WAS DUE TO ERROR ON THE PART OF THE STAFF MEMBER AND NOT DUE TO ANY FAILURE OF THE COT.

  Patient problems: Insufficient Information

  MAUDE report 17694418 ↗
• MalfunctionOct 20, 2022Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED AN INABILITY TO ADJUST THE COT HEIGHT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15640452 ↗
• MalfunctionApr 26, 2022Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED THE FOWLER STUCK IN A RAISED POSITION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14209514 ↗
• MalfunctionJan 19, 2022Protective Measures Problem; Protective Measures Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED INADEQUATE PATIENT RESTRAINT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13294233 ↗
• MalfunctionJan 19, 2022Device Fell; Device Fell

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED A COT DROP. THERE WERE 2 EVENTS WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13294105 ↗
• MalfunctionApr 22, 2021Device Fell; Device Fell

  IT WAS ORIGINALLY REPORTED THAT 1 EVENT OCCURRED WHERE THERE WAS A FOWLER COLLAPSE; HOWEVER, UPON COMPLETION OF THE FINAL INVESTIGATION, THE DEVICE WAS EXPERIENCING A GATCH COLLAPSE, WHICH IS NOT REPORTABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11710779 ↗
• MalfunctionOct 27, 2020Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE FOWLER WAS STUCK.  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10743770 ↗
• MalfunctionJul 29, 2019Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE COT COULD NOT REACH LOAD HEIGHT. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WERE NO CONSEQUENCES OR IMPACTS TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8835686 ↗
• MalfunctionMay 15, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL OFF THE STRETCHER AS THE STRETCHER WAS BEING TILTED DOWN. IT WAS REPORTED THAT THE PATIENT WAS BEING TRANSPORTED DUE TO A GUN SHOT WOUND. IT WAS REPORTED THAT THE PATIENT PASSED AWAY.

  Patient problems: Death; Fall

  MAUDE report 8613535 ↗
• MalfunctionJan 25, 2019Device Fell; Device Fell

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THERE WAS A COT DROP. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WERE NO CONSEQUENCES OR IMPACTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8279173 ↗
• MalfunctionJan 25, 2019Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE COT HEIGHT COULD NOT BE ADJUSTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8279167 ↗
• InjuryOct 1, 2018Mechanical Problem

  IT WAS REPORTED THAT THE COT LEGS DID NOT LOCK WHEN THE COT WAS PULLED OUT OF THE AMBULANCE AND THE COT DROPPED. THE PATIENT SUFFERED A FRACTURED FEMUR. IT WAS ALSO REPORTED THAT THE PATIENT HAS PAGETS DISEASE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 7923921 ↗