MAUDE Adverse Event Report: Stryker Medical-Kalamazoo POWER-PRO XT; Stretcher, Wheeled

Catalog Number	6506000000
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported through the filing of a lawsuit that while being transported on the device on three separate occasions (b)(6) 2025), the patient allegedly suffered injuries during loading and/or unloading by being tipped, shifting, or falling from the power-pro xt powered ambulance cot.It is further alleged that these incidents were factors in causing the patient¿s wrongful death on (b)(6) 2025.

• Brand Name: POWER-PRO XT
• 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 ; +1(269)329-2100
• MDR Report Key: 50675847
• Report Number: 0001831750-2026-00058
• Device Sequence Number: 20146947
• Product Code: FPO
• UDI-Device Identifier: 07613327261639
• UDI-Public: 07613327261639
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: 6506000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 09/08/2026
• 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