MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO M-1 COT - BASE HIGH LOAD 28; STRETCHER, WHEELED

Catalog Number	6100003000
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
Updated sections b, d, h.

• Brand Name: M-1 COT - BASE HIGH LOAD 28
• Common Device Name: STRETCHER, WHEELED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 20249659
• Report Number: 0001831750-2024-01068
• Device Sequence Number: 15274459
• Product Code: FPO
• UDI-Device Identifier: 07613327261530
• UDI-Public: (01)07613327261530(21)080140767
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6100003000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6100031000,M-1 COT KNEE GATCH LITTER
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown