MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER-PRO TL COT; STRETCHER, WHEELED

Catalog Number	6550000000
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/19/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died following an accident in an ambulance.Further information has not been provided at this time.
Additional Manufacturer Narrative
The device catalog number and gtin number have been corrected in section d4.
Event or Problem Description
It was reported that the patient died following an accident in an ambulance.Further information has not been provided at this time.
Additional Manufacturer Narrative
The device was not accessible for evaluation.A review of the information provided indicated that the shoulder restraints were not used.Further information surrounding the incident was not available as the alleged issue has on-going legal matters.
Event or Problem Description
It was reported that the patient died following an accident in an ambulance.

• Brand Name: POWER-PRO TL COT
• 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: 17881927
• Report Number: 0001831750-2023-01017
• Device Sequence Number: 7389951
• Product Code: FPO
• UDI-Device Identifier: 07613327261660
• UDI-Public: 07613327261660
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2024

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: 6550000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 09/26/2023; 09/26/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 12/20/2023; 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown