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

Catalog Number	6506000000
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 41 malfunction events, where it was reported the devices, experienced cot height cannot be adjusted or fowler cannot be lowered.No adverse consequence or clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.35 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.6 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This report summarizes 39 malfunction events, instead of 41.
Additional Manufacturer Narrative
1 device that was pending was evaluated in the field but the issue was not confirmed; no defect or malfunction was found.1 pending device was not evaluated, but reviewed by data and confirmed the issue.4 devices that were pending evaluation were evaluated in the field and the issue was confirmed.The devices were repaired on site and returned to service.1 device that was evaluated, was determined the device experienced loss of electric function, which is not reportable.Section h codes have been updated to reflect this.

• 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 21925781
• Report Number: 0001831750-2025-00678
• Device Sequence Number: 8795104
• Product Code: FPO
• UDI-Device Identifier: 07613327261639
• UDI-Public: 07613327261639
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 39
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: 6506000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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