MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 6507 POWER PRO 2, HIGH CONFIG; STRETCHER, WHEELED

Catalog Number	650705550001
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.46 device(s) was/were functionally/visually inspected in the field.The device(s) was/were repaired and returned to use.Evaluation results findings (components/results): 5 devices: cable; electrical / electrical/electronic component problem identified, 7 devices: chassis/frame / deformation problem, 7 devices: chassis/frame / mechanical problem identified, 3 devices: chassis/frame / device migration, 1 device: chassis/frame / dust or dirt problem identified, 1 device: circuit board / electrical/electronic component problem identified, 1 device: circuit board / short circuit, 2 devices: circuit board / failure to calibrate or used out of calibration, 6 devices: computer software / failure to calibrate or used out of calibration, 1 device: electrical port / electrical/electronic component problem identified, 1 device: fastener / mechanical problem identified, 4 devices: hydraulic system / device migration, 1 device: gauges/meters / wear problem, 2 devices: sensor / electrical/electronic component problem identified, 1 device: chassis/frame / wear problem, 1 device: cable; electrical; cable; mechanical/structural; circuit board; gauges/meters / electrical/electronic component problem identified; mechanical problem identified, 1 device: connector/coupler / electrical/electronic component problem identified, 1 device: cylinder / device migration.5 devices are pending evaluation.Evaluation results findings (components/results): 5 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 october 1-december 31, 2025.This report summarizes 51 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.
Additional Manufacturer Narrative
The 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: fastener/device migration.1 device: computer software/failure to calibrate or used out of calibration.3 devices that were pending evaluation were evaluated, but the reported issue was not confirmed.Evaluation results findings (components/results): 3 devices: appropriate term/code not available/no findings available.
Event or Problem Description
No new information.

• Brand Name: 6507 POWER PRO 2, HIGH CONFIG
• 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: 24199653
• Report Number: 0001831750-2026-99144
• Device Sequence Number: 5430970
• Product Code: FPO
• UDI-Device Identifier: 07613327559118
• UDI-Public: 7613327559118
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 51
• 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): 03/27/2026

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: 650705550001
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/01/2026
• Supplement Date Received by Manufacturer: 01/01/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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