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

Catalog Number	6506000000
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.23 device(s) was functionally/visually inspected in the field.The device(s) was/were repaired and returned to use.1 device was not evaluated, as a probable cause for the issue was identified during communication between the customer and stryker and no further assistance was requested by the customer.Evaluation results findings (components/results): 1 device: caster; chassis/frame; slide / mechanical problem identified.1 device: chassis/frame / deformation problem.1 device: chassis/frame / wear problem.1 device: chassis/frame; fastener / deformation problem; mechanical problem identified.1 device: coil / wear problem.1 device: housing / wear problem.1 device: pin / deformation problem.1 device: post / device migration.1 device: switch/relay / electrical/electronic component problem identified.2 devices: chassis/frame / dust or dirt problem identified.3 devices: chassis/frame / mechanical problem identified.4 devices: controller / mechanical problem identified.6 devices: plunger / deformation problem.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between july 1-september 30, 2025.This report summarizes 24 malfunction event(s), where it was reported the device experienced inability to disengage the cot from the cot fastener.No adverse consequence or clinically relevant delay in treatment was reported.
Event or Problem Description
This report now summarizes 23 malfunction event(s), instead of 24.
Additional Manufacturer Narrative
1 device that was evaluated and was determined the device experienced not charging, which is not reportable.

• 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: 23394075
• Report Number: 0001831750-2025-99462
• Device Sequence Number: 18628215
• Product Code: FPO
• UDI-Device Identifier: 07613327261639
• UDI-Public: 7613327261639
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 23
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/06/2025
• 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