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

Catalog Number	1115000000X
Medical Device Problem Code	Device Fell (4014)
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 1 malfunction events(s), where it was reported the devices experienced siderail unexpected drop/collapse.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(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: side rail / mechanical problem identified.There was no remedial action taken.This device is not labeled for single use.
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 unexpected drop/collapse 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 #0001831750-2021-00653 was originally submitted on february 21st, 2021.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.
Event or Problem Description
No new information.

• Brand Name: BIG WHEEL STRETCHER, PRIME X
• 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: 23393625
• Report Number: 0001831750-2025-99408
• Device Sequence Number: 18602979
• Product Code: FPO
• UDI-Device Identifier: 07613327278248
• UDI-Public: 7613327278248
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 1
• 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): 11/03/2025

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: 1115000000X
• 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: 10/27/2025
• Supplement Report FDA Received Date: 11/03/2025
• 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