MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER LOAD; STRETCHER, WHEELED

Catalog Number	6390000000
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a fire.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
A visual and functional was performed.It was found that the fire in the ambulance was not related to any component-level defect in the unit.It was further reported that the fire was initiated when the patient set himself on fire, which subsequently led to damage to the unit during the use of a fire extinguisher.The issue was resolved for the customer by informing them that the product is no longer approved for use on patients.
Event or Problem Description
New information: it was reported that the patient set himself on fire.

• Brand Name: POWER LOAD
• 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: marleca lane ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 23267418
• Report Number: 0001831750-2025-00733
• Device Sequence Number: 13298504
• Product Code: FPO
• UDI-Device Identifier: 07613327261523
• UDI-Public: (01)07613327261523
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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
• Device Catalogue Number: 6390000000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2023
• 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
• Patient Sex: Unknown