MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO MX-PRO R-3 AMBULANCE COT; STRETCHER, WHEELED

Catalog Number	6082000000
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.4 device(s) was functionally/visually inspected in the field.The device(s) was/were repaired and returned to use.Evaluation results findings (components/results).1 device: locking mechanism / wear problem.1 device: chassis/frame / deformation problem.2 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 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 4 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.

• Brand Name: MX-PRO R-3 AMBULANCE COT
• 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: 23393624
• Report Number: 0001831750-2025-99407
• Device Sequence Number: 9844636
• Product Code: FPO
• UDI-Device Identifier: 07613327261547
• UDI-Public: 7613327261547
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

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: 6082000000
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/27/2025
• 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