MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 6507 POWER PRO 2, HIGH CONFIG; STRETCHER, WHEELED

Catalog Number	650705550001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/17/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that there was an ambulance accident.The patient being transported passed away as a result of injuries sustained in the crash.The coroner¿s office believes the cot restraints may have contributed to the patient¿s injuries, but this has not been confirmed.
Additional Manufacturer Narrative
In response to the alleged event, a stryker qae contacted a stryker field service technician and a stryker sales account manager for further information.The stryker field service technician stated that he spoke to a manager, a lieutenant, at the account that confirmed the ambulance accident did occur and the coroner did not conduct an autopsy.He also confirmed that the patient was not in good health prior to the accident and had an external port of some kind in their abdominal area.This port was disturbed by the force of the impact from the accident.The patient was transported by another ambulance to the hospital after the accident who was alive and stable.The stryker sales account manager responded, saying the stryker field service technician has been the one on-site to inspect the equipment and has maintained communication with the customer.Therefore, the stryker sales account manager could not provide any additional information other than the frame of the cot is bent and could have even further, unseen, stresses/damages even beyond what is visible.As a result of this report, a visual and functional inspection was performed by the stryker field service technician.It was found that the issues for the cot involved in the ambulance accident was not due to any component level defect with the product.Based on the post-accident inspection and photos provided in the work order, a stryker qae determined the unit should be removed from use (rfu).The issue was resolved for the customer by performing a post-accident inspection, recommending removing the cot from use (rfu), and ensuring nothing else was needed from stryker.
Event or Problem Description
It was reported that there was an ambulance accident.The patient being transported passed away as a result of injuries sustained in the crash.The coroner's office believes the cot restraints may have contributed to the patient¿s injuries, but this has not been confirmed.

• Brand Name: 6507 POWER PRO 2, HIGH CONFIG
• 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: alex wibert ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 23881840
• Report Number: 0001831750-2025-00753
• Device Sequence Number: 20010209
• Product Code: FPO
• UDI-Device Identifier: 07613327559118
• UDI-Public: (01)07613327559118
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: 650705550001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2025
• 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