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 Codes	Pain (1994); Insufficient Information (4580); 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.44 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: actuator / mechanical problem identified, 1 device: cable; electrical; sensor / electrical/electronic component problem identified, 1 device: cable; mechanical/structural / device migration, 1 device: chassis/frame / deformation problem; mechanical problem identified, 1 device: chassis/frame / device migration, 1 device: chassis/frame / dust or dirt problem identified, 1 device: circuit board / failure to calibrate or used out of calibration, 1 device: circuit board; controller; led (light emitting diode) / electrical/electronic component problem identified; wear problem, 1 device: computer software / software problem identified, 1 device: connector/coupler / device migration, 1 device: connector/coupler / electrical/electronic component problem identified, 1 device: connector/coupler; gauges/meters / electrical/electronic component problem identified; wear problem, 1 device: fastener / mechanical problem identified, 1 device: gauges/meters / wear problem, 1 device: pin / device migration, 1 device: sensor / failure to calibrate or used out of calibration, 2 devices: battery / energy storage system problem, 2 devices: circuit board / electrical/electronic component problem identified, 2 devices: hydraulic system / mechanical problem identified, 2 devices: tube / dust or dirt problem identified, 3 devices: chassis/frame / deformation problem, 3 devices: chassis/frame / mechanical problem identified, 4 devices: cable; mechanical/structural / mechanical problem identified, 5 devices: cable; electrical / electrical/electronic component problem identified, 6 devices: computer software / failure to calibrate or used out of calibration, 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 45 malfunction event(s), where it was reported the device experienced difficult to load/unload the cot in the ambulance.There was 1 event with patient involvement; it was not known what the patient experienced.
Additional Manufacturer Narrative
1 device that was originally coded as evaluated was found after investigation that the device experienced loss of electric function which is not reportable.
Event or Problem Description
This report summarizes 44 malfunction event(s), instead of 45.
Additional Manufacturer Narrative
This supplemental is being filed to update a clinical signs code following the completion of a device investigation.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An additional event was identified and therefore added to this summary report.
Event or Problem Description
This report now summarizes 45 malfunction event(s), instead of 44.

• 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: 23383853
• Report Number: 0001831750-2025-99281
• Device Sequence Number: 8752948
• 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: 45
• 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): 01/06/2026

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): 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: 10/24/2025
• Supplement Report FDA Received Date: 12/18/2025; 12/23/2025; 01/06/2026
• 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