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

Model Number	6550
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that an ambulance equipped with a power-pro tl cot was in a collision; the impact caused the patient to slide up the cot, and their legs flung upward.Based on this scenario, it is likely the restraints did not adequately prevent the patient's legs from moving.There were no reported adverse consequences to the patient.
Additional Manufacturer Narrative
The device evaluation has been completed and section h codes have been updated.
Event or Problem Description
The customer reported that an ambulance equipped with a power-pro tl cot was in a collision; the impact caused the patient to slide up the cot, and their legs flung upward.Based on this scenario, it is likely the restraints did not adequately prevent the patient's legs from moving.There were no reported adverse consequences to the patient.

• Brand Name: POWER-PRO TL COT
• Common Device Name: STRETCHER - WHEELED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 11316457
• Report Number: 0001831750-2021-00593
• Device Sequence Number: 19771568
• 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
• Report Date (Section B): 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6550
• Device Catalogue Number: 6550000000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1