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

Catalog Number	6506000000
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
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.143 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.Evaluation results findings (components/results).1 device: bearings; magnet; slide; spring / mechanical problem identified; wear problem.1 device: bolt / mechanical problem identified.1 device: bolt / device migration.1 device: bolt; tube / mechanical problem identified.1 device: cap / mechanical problem identified.3 devices: caster / device migration.41 devices: chassis/frame / mechanical problem identified.8 devices: chassis/frame / device migration.2 devices: chassis/frame / deformation problem.6 devices: circuit board / electrical/electronic component problem identified.1 device: circuit board; connector/coupler / electrical/electronic component problem identified.1 device: clamp / device migration.3 devices: fastener / mechanical problem identified.5 devices: fastener / device migration.2 devices: fastener; socket / device migration; mechanical problem identified.1 device: locking mechanism / mechanical problem identified.1 device: locking mechanism / device migration.1 device: locking mechanism / wear problem.7 devices: pin / wear problem.1 device: pin / device migration.10 devices: rod/shaft / deformation problem.5 devices: rod/shaft / mechanical problem identified.3 devices: rod/shaft / device migration.1 device: screw / device migration.4 devices: socket / mechanical problem identified.2 devices: spring / device migration.1 device: switch/relay / electrical/electronic component problem identified.1 device: tube / mechanical problem identified.1 device: tube / dust or dirt problem identified.18 devices: weld / deformation problem.3 devices: weld / mechanical problem identified.1 device: wheel / device migration.1 device: hydraulic system / mechanical problem identified.1 device: chassis/frame; sensor / electrical/electronic component problem identified; mechanical problem identified.1 device: rod/shaft / deformation problem; device migration.1 device: rod/shaft / dust or dirt problem identified.1 device: socket / dust or dirt problem identified.2 devices were not evaluated and no cause was determined, as the customers did not make the devices accessible for testing.Evaluation results findings (components/results).2 devices: appropriate term/code not available/no findings available.6 devices are pending evaluation.Evaluation results findings (components/results).6 devices: insufficient information / results pending completion of investigation.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 january 1- march 31, 2026.This report summarizes 151 malfunction events(s), where it was reported the devices experienced difficult to load/unload the cot in the ambulance.No adverse consequence or clinically relevant delay in treatment was reported.

• 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: 24967404
• Report Number: 0001831750-2026-99271
• Device Sequence Number: 13369166
• 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: 151
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/23/2026
• 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