MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO M-1 COT KNEE GATCH LITTER; STRECHER, WHEELED

Catalog Number	6100031000
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/12/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
H3 other text: the customer stated that the device did not cause the tip and did not request an evaluation.
Event or Problem Description
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.

• Brand Name: M-1 COT KNEE GATCH LITTER
• Common Device Name: STRECHER, 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17694418
• Report Number: 0001831750-2023-00995
• Device Sequence Number: 12273121
• Product Code: FPO
• UDI-Device Identifier: 07613327261561
• UDI-Public: 07613327261561
• Combination Product (Y/N): Y
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2023

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?: No
• Device Catalogue Number: 6100031000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2015
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 83 YR
• Patient Sex: Female