MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 6506 MTS PWRPRO COT HIGH CNFIG; STRETCHER, WHEELED

Catalog Number	650605550003
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
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 19 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
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.18 device(s) was functionally/visually inspected in the field.The device(s) was/were repaired and returned to use.1 device is pending evaluation.Evaluation results findings (components/results).1 device: appropriate term/code not available / results pending completion of investigation.1 device: caster / deformation problem.1 device: caster / mechanical problem identified.1 device: rod/shaft / wear problem.1 device: tube / deformation problem.2 devices: chassis/frame / deformation problem.2 devices: circuit board / electrical/electronic component problem identified.2 devices: rod/shaft / deformation problem.3 devices: fastener / device migration.5 devices: chassis/frame / mechanical problem identified.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This report now summarizes 18 malfunction event(s), instead of 19.
Additional Manufacturer Narrative
The device that was pending was evaluated and it was determined the device experienced loss of electric function, which is not reportable.One of the devices had an updated results code following the completion of a device investigation.

• Brand Name: 6506 MTS PWRPRO COT HIGH CNFIG
• 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: 23383697
• Report Number: 0001831750-2025-99251
• Device Sequence Number: 12941166
• Product Code: FPO
• UDI-Device Identifier: 07613327513271
• UDI-Public: 7613327513271
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 18
• 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): 01/29/2026

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: 650605550003
• 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
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 01/29/2026
• 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