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.144 device(s) was functionally/visually inspected in the field.The device(s) was/were repaired and returned to use.2 devices were not evaluated and no cause was determined, as the customers did not make the devices accessible for testing.13 devices are pending evaluation.Evaluation results findings (components/results) 1 device: bearings / mechanical problem identified 1 device: bearings; slide; spring / deformation problem; dust or dirt problem identified; mechanical problem identified 1 device: bearings; weld / mechanical problem identified 1 device: bolt / wear problem 1 device: bolt; washer / device migration 1 device: chassis/frame / dust or dirt problem identified 1 device: chassis/frame / wear problem 1 device: chassis/frame; circuit board / electrical/electronic component problem identified; wear problem 1 device: circuit board; computer hardware / electrical/electronic component problem identified 1 device: circuit board; sensor / electrical/electronic component problem identified 1 device: circuit board; switch/relay / electrical/electronic component problem identified; mechanical problem identified 1 device: connector/coupler / mechanical problem identified 1 device: cover; tube / mechanical problem identified 1 device: handpiece / mechanical problem identified 1 device: housing; screw / device migration 1 device: hydraulic system / mechanical problem identified 1 device: locking mechanism / mechanical problem identified 1 device: locking mechanism / wear problem 1 device: locking mechanism; pin / dust or dirt problem identified 1 device: locking mechanism; spring / dust or dirt problem identified; wear problem 1 device: pin / device migration 1 device: pin / mechanical problem identified 1 device: pin / wear problem 1 device: rod/shaft / wear problem 1 device: rod/shaft; wheel / device migration; wear problem 1 device: rod/shaft; wheel / mechanical problem identified 1 device: screw / device migration 1 device: screw / mechanical problem identified 1 device: spring / mechanical problem identified 1 device: tube / deformation problem 1 device: tube / device migration 1 device: weld / mechanical problem identified 1 device: weld / wear problem 1 device: wheel / dust or dirt problem identified 1 device: wheel / mechanical problem identified 10 devices: rod/shaft / deformation problem 12 devices: weld / deformation problem 13 devices: appropriate term/code not available / results pending completion of investigation 15 devices: circuit board / electrical/electronic component problem identified 2 devices: appropriate term/code not available / no findings available 2 devices: caster / mechanical problem identified 2 devices: rod/shaft / device migration 2 devices: rod/shaft / mechanical problem identified 2 devices: rod/shaft; weld / deformation problem 2 devices: socket / mechanical problem identified 1 device: spring / device migration 3 devices: spring / dust or dirt problem identified 2 devices: tube / mechanical problem identified 3 devices: caster / device migration 3 devices: wheel / device migration 38 devices: chassis/frame / mechanical problem identified 4 devices: chassis/frame / deformation problem 4 devices: chassis/frame / device migration 4 devices: fastener / device migration.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 159 malfunction event(s), where it was reported the device experienced difficult to load/unload the cot in the ambulance.No adverse consequence or clinically relevant delay in treatment was reported.
Event or Problem Description
This report now summarizes 157 malfunction event(s), instead of 159.
Additional Manufacturer Narrative
The device that was pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Evaluation results findings (components/results) 1 device: circuit board/electrical/electronic component problem identified.1 device that was pending evaluation was not made available by the customer; the reported issue was not confirmed.Evaluation results findings (components/results) 1 device: appropriate term/code not available/no findings available.1 device that was pending was evaluated in the field but the issue was not confirmed; no defect or malfunction was found.1 device that was originally coded as not made available by the customer was communicated with the field service representative, and it was identified that the device had no defect, and the issue was reported in error.11 devices are still pending evaluation.
Additional Manufacturer Narrative
2 devices that were pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Evaluation results findings (components/results) 1 device: wheel/mechanical problem identified 1 device: chassis/frame/mechanical problem identified 2 devices were not evaluated as the cause was determined by analyzing data provided by the user/third party; no further assistance was requested by the customer.Evaluation results findings (components/results) 2 devices: chassis/frame/device migration 1 device that was pending evaluation was not made available by the customer; the reported issue was not confirmed.Evaluation results findings (components/results) 1 device: appropriate term/code not available/no findings available 5 devices are still pending evaluation.
Event or Problem Description
No new information.
Event or Problem Description
This report now summarizes 155 malfunction event(s), instead of 156.
Additional Manufacturer Narrative
2 devices that were pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Evaluation results findings (components/results).1 device: chassis/frame/mechanical problem identified.1 device: rod/shaft/mechanical problem identified.2 device that were pending evaluation were not made available by the customer; the reported issue was not confirmed.Evaluation results findings (components/results).2 devices: appropriate term/code not available/no findings available.Initially it was reported that there were 2 instances of this hazard/model number combination.Further review of records identified that one record was a duplicate.The number of events summarized 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: 23394097
• Report Number: 0001831750-2025-99468
• Device Sequence Number: 9945899
• 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: 155
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/27/2026

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
• 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; 10/01/2025; 10/01/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/02/2025; 01/20/2026; 02/27/2026
• 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