M1 6100 (REF 6100-003-000)Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 07613327261530), received between Apr 24, 2018 and Apr 23, 2026 — classified as 7 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Device Fell” (36 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 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Difficult to Remove

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1- MARCH 31, 2026. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED INABILITY TO DISENGAGE THE COT FROM THE COT FASTENER. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967209 ↗
• MalfunctionOct 27, 2025Difficult or Delayed Positioning; Device Tipped Over; Difficult or Delayed Positioning; Device Tipped Over

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1-SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED DIFFICULT TO LOAD/UNLOAD THE COT IN THE AMBULANCE AND UNSTABLE COT LEADING TO TIP. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT: THE PATIENT EXPERIENCED UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393621 ↗
• MalfunctionOct 27, 2025Device Fell; Device Fell

  THIS REPORT NOW SUMMARIZES 1 MALFUNCTION EVENT(S), INSTEAD OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393056 ↗
• MalfunctionApr 28, 2025Device Tipped Over; Device Tipped Over

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED UNSTABLE COT LEADING TO TIP. THERE WAS XXX EVENT WITH PATIENT INVOLVEMENT THE PATIENT EXPERIENCED ABRASION; HEAD INJURY; LACERATION(S).

  Patient problems: Abrasion; Head Injury; Laceration(s)

  MAUDE report 21920129 ↗
• MalfunctionOct 29, 2024Difficult to Remove; Difficult to Remove

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED INABILITY TO DISENGAGE THE COT FROM THE COT FASTENER. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; THE PATIENT EXPERIENCED A HEMATOMA.

  Patient problems: Hematoma

  MAUDE report 20560289 ↗
• MalfunctionSep 18, 2024Device Fell; Device Fell

  IT WAS REPORTED THAT WHEN FOLDING BACK THE OPTIONAL CARRYING HANDLE OF THE CHASSIS AT THE HEAD END, THE CARRYING HANDLE WAS ALREADY FOLDED BACK MORE THAN 90°, LIGHTLY TOUCHED THE RED RELEASE HANDLE OF THE OPTIONAL CARRYING HANDLE, WHEREUPON THE HEAD-SIDE LOCKING MECHANISM RELEASED IMMEDIATELY AND THE COT LOWERED ABRUPTLY WITH THE PATIENT LYING ON IT UPSIDE DOWN TO THE FLOOR. THERE WERE NO INJURIES TO THE PATIENT, BUT A USER WAS SLIGHTLY INJURED WHILE TRYING TO PREVENT THE COT FROM SINKING. IN RESPONSE TO THE REPORTED INCIDENT, ATTEMPTS WERE MADE TO GATHER FURTHER DETAILS ABOUT THE INJURY AND ANY TREATMENT PROVIDED TO THE CAREGIVER. HOWEVER, ADDITIONAL INFORMATION REGARDING THE EXTENT OF THE INJURIES OR TREATMENT WAS UNAVAILABLE. IT WAS CONFIRMED THAT A LOCAL SERVICE PROVIDER HAD VISITED THE SITE AND RESOLVED THE ISSUE. IT WAS REPORTED THAT THE EVENT WAS ATTRIBUTED TO AN ERROR MADE DURING MAINTENANCE BY THE SERVICE PROVIDER MOST LIKELY ATTRIBUTED TO THE ALIGNMENT/ADJUSTMENT OF THE BASE TUBE/FRAME ASSEMBLY. IT WAS REPORTED THAT NO FURTHER ACTION WAS DEEMED NECESSARY FROM STRYKER AFTER REPAIR FROM THE LOCAL SERVICE PROVIDER.

  Patient problems: Insufficient Information

  MAUDE report 20249659 ↗
• MalfunctionJul 29, 2024Device Fell; Device Fell

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED UNINTENDED COT LOWERING OR COT DROPPING TO LOWEST POSITION (NO COT TIP). THERE WERE 4 EVENTS WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19850320 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE TIPPED OVER DURING TRANSPORT BETWEEN AMBULANCE AND HOSPITAL. THERE WAS A SINGLE OPERATOR AT THE FOOT END, WHO ATTEMPTED TO CATCH THE COT AND RESTRAIN PATIENT DURING THE TIP. IT WAS FURTHER REPORTED THAT BOTH THE PATIENT AND PARAMEDIC WERE ASSESSED FOR INJURIES AT THE HOSPITAL. THE PATIENT WAS ASSESSED FOR A HEAD INJURY, AND THE USER WAS ASSESSED FOR AN ARM INJURY, BOTH AS A RESULT OF THE INCIDENT.

  Patient problems: Head Injury; Insufficient Information

  MAUDE report 19613647 ↗
• MalfunctionApr 23, 2024Device Fell; Device Fell

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED UNINTENDED COT LOWERING OR COT DROPPING TO LOWEST POSITION (NO COT TIP). THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19163130 ↗
• MalfunctionApr 23, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED DIFFICULT TO LOAD/UNLOAD THE COT IN THE AMBULANCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19162983 ↗
• MalfunctionJan 24, 2024Device Tipped Over; Device Tipped Over

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED UNSTABLE COT LEADING TO TIP. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18573191 ↗
• MalfunctionJan 24, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED DIFFICULT TO LOAD/UNLOAD THE COT IN THE AMBULANCE. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18573190 ↗
• MalfunctionJan 24, 2024Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED COT HEIGHT CANNOT BE ADJUSTED. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18573189 ↗
• MalfunctionJan 24, 2024Device Fell; Device Fell

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FOWLER UNEXPECTED DROP/COLLAPSE. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18573186 ↗
• MalfunctionOct 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED COT DISENGAGES FROM FASTENER UNEXPECTEDLY. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT THE PATIENT EXPERIENCED PAIN.

  Patient problems: Pain

  MAUDE report 18007352 ↗
• MalfunctionOct 25, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED DIFFICULT TO MANEUVER UNIT WHICH DOES NOT RESULT IN A TIP. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007258 ↗
• MalfunctionOct 25, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED DIFFICULT TO LOAD/UNLOAD THE COT IN THE AMBULANCE. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007206 ↗
• MalfunctionOct 25, 2023Device Fell; Device Fell

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED UNINTENDED COT LOWERING OR COT DROPPING TO LOWEST POSITION (NO COT TIP). THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007205 ↗
• MalfunctionJul 24, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED DIFFICULT TO LOAD/UNLOAD THE COT IN THE AMBULANCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377924 ↗
• MalfunctionJul 24, 2023Device Fell; Device Fell

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED UNINTENDED COT LOWERING OR COT DROPPING TO LOWEST POSITION. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377354 ↗
• MalfunctionApr 26, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED DIFFICULT TO LOAD/UNLOAD THE COT IN THE AMBULANCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16819501 ↗
• MalfunctionApr 26, 2023Device Fell; Device Fell

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED UNINTENDED COT LOWERING OR COT DROPPING TO LOWEST POSITION. THERE WERE 3 EVENTS WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16819484 ↗
• InjuryFeb 2, 2023Device Tipped Over; Device Tipped Over

  IT WAS REPORTED THAT DURING THE COURSE OF AN INTENSIVE CARE TRANSFER WITH THE RESCUE AND INTENSIVE CARE TRANSPORT HELICOPTER, A CRITICALLY ILL PATIENT WITH CIRCULATORY INSTABILITY WAS ON THE WAY FROM THE HOSPITAL BUILDING TO THE HELIPAD, WHEN THE COT TIPPED OVER SIDEWAYS WITH THE PATIENT. THE COT WAS GUIDED AT THE FRONT BY THE EMERGENCY PARAMEDIC AND AT THE BACK BY THE EMERGENCY PHYSICIAN. THREE MEDICAL DEVICES (HOLDER WITH THREE SYRINGE PUMPS, PATIENT MONITOR WITH DEFIB UNIT AND THE MOBILE OXYGEN BOTTLE) WERE ATTACHED TO THE SIDE, ON THE RIGHT IN THE DIRECTION OF TRAVEL, AND THE VENTILATOR WAS ATTACHED TO THE HEAD END OF THE COT. BY DRIVING AROUND OBSTACLES (PARKED CAR, OVERTURNED CONSTRUCTION SITE ELEMENT AND CONTAINER IN THE ACCESS AREA TO THE LANDING SITE) AND CROSSING A WATER DRAIN, THE COT WITH THE PATIENT WEIGHING APPROX. 70KG TIPPED OVER TO THE RIGHT (THE SIDE WITH THE EQUIPMENT) IN A LEFT TURN. THE COT FELL ONTO ITS RIGHT SIDE AND THE FALL WAS INTERCEPTED BY THE EQUIPMENT MOUNTED THERE. THIS DESTROYED THE SYRINGE PUMP WITH THE CATECHOLAMINE IT CONTAINED, AS WELL AS THE PATIENT MONITOR. THE PATIENT WAS SECURED FROM FALLING BY THE STRAPS OF THE COT. ONLY THEIR HEAD TOUCHED T

  Patient problems: Abrasion

  MAUDE report 16284946 ↗
• MalfunctionJan 26, 2023Device Fell; Device Fell

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED UNINTENDED COT LOWERING OR COT DROPPING TO LOWEST POSITION (NO COT TIP). THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250568 ↗
• MalfunctionNov 4, 2022Device Fell; Device Fell

  IT WAS REPORTED THAT THERE WAS A COT DROP. THE COT DROPPED UNTO THE FOOT OF THE PARAMEDIC. AS A RESULT, HE TOOK MEDICAL LEAVE, RECEIVED COOLING TREATMENT, AND WAS GIVEN PAIN MEDICATION. THERE WAS A PATIENT ON THE DEVICE DURING THE COT DROP, BUT NO ADVERSE CONSEQUENCES OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED FOR THE PATIENT.

  Patient problems: Discomfort; Pain

  MAUDE report 15738168 ↗