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

Catalog Number	650705550001
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Discomfort (2330); Muscle/Tendon Damage (4532); 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.90 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.8 devices were 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.27 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This report summarizes 125 malfunction events(s), where it was reported the devices experienced false engagement of handle in the upright or horizontal position.There was 1 event with patient involvement; the patient experienced discomfort.
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 (results/components): 1 device: wear problem/latch.26 devices are still pending evaluation.
Event or Problem Description
1 device that was pending evaluation was evaluated in the field and it was further reported that there was a patient involved that experienced muscle/tendon damage.
Additional Manufacturer Narrative
The 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) 26 devices: latch/mechanical problem identified.
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: 22608285
• Report Number: 0001831750-2025-99213
• Device Sequence Number: 10106060
• 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: 125
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2025

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: 650705550001
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 07/01/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/25/2025; 11/19/2025
• 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