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

Catalog Number	6506000000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device was being positioned to transfer a paraplegic patient with her legs bent, as requested.The wheels on the head side were previously unlocked for maneuvering in the corridors - the stretcher was moved next to the bed and the brakes on the wheels on the foot side were applied.In order to bring the foot section back into the neutral position, the staff member previously standing at the head end had to support the staff member at the foot end.While the foot section was being put back into the flat position, the patient slipped between the hospital bed and the stretcher and fell onto the floor from a height of approx.1m.Presumably the stretcher at the head end moved away from the hospital bed.Initially, the patient reported pain in her head and arm.Further examination found a subdural hematoma was found during the diagnosis.
Event or Problem Description
There is no new information to report.
Additional Manufacturer Narrative
As a result of the reported event, a stryker raqa specialist reached out to a stryker field service engineer for more information on the evaluation of the unit.It was stated that no inspection took place as the customer stated that no inspection was required.Based on this information, it was determined that the alleged unintended cot lowering or cot dropping to lowest position (no cot tip) was likely due to no defect with the unit, and instead, use error.The users only applied the brake to one side.As a result of the reported injury, a stryker quality assurance engineer reached out to a stryker raqa specialist for more patient information, however none could be provided, beyond the initial report of hematoma and pain.The issue was resolved for the customer by ensuring nothing else was needed from stryker.

• 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: marleca lane ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 22289676
• Report Number: 0001831750-2025-00708
• Device Sequence Number: 15533638
• Product Code: FPO
• UDI-Device Identifier: 07613327261639
• UDI-Public: (01)07613327261639
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2017
• 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: Other
• Patient Sex: Unknown