MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME BIG WHEEL STRETCHER 30"; STRETCHER, WHEELED

Catalog Number	1115000030
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 2 malfunction events(s), where it was reported the devices experienced brakes do not remain engaged.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.1 device was functionally/visually inspected in the field.The device was repaired and returned to use.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Additional Manufacturer Narrative
Adding an additional device to this summary report.1 device is still pending evaluation.
Event or Problem Description
This report now summarizes 3 malfunction events(s), instead of 2.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
In accordance with the ¿final guidance on medical device reporting for manufacturers¿ issued on november 7, 2016, stryker medical will no longer report the hazard of brakes do not remain engaged; unexpectedly disengage during use for our stretcher lines (product code fpo), as this hazard has not caused or contributed to any serious injuries in at least two years.The last serious adverse event manufacturer report #0001831750-2020-00300 was originally submitted on february 7th, 2020.While no new mdrs will be generated for this hazard moving forward, additional supplemental records may be submitted for past reported events if new information becomes available.Should a new serious adverse event occur attributed to this hazard, mdr reporting will resume.
Additional Manufacturer Narrative
The device that was pending evaluation was not made available by the customer; the reported issue was not confirmed.Evaluation results findings (components/results).1 device: appropriate term/code not available/no findings available.
Event or Problem Description
No new information.

• Brand Name: PRIME BIG WHEEL STRETCHER 30"
• 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: 22575812
• Report Number: 0001831750-2025-99053
• Device Sequence Number: 18566870
• Product Code: FPO
• UDI-Device Identifier: 07613327278330
• UDI-Public: 7613327278330
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 3
• 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): 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: 1115000030
• 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; 07/01/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 07/24/2025; 08/01/2025; 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