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

Catalog Number	1115000030
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 77 malfunction events, where it was reported the devices experienced fluid leaks onto floor.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.73 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.2 devices were not evaluated and no cause was determined, as the customers did not make the devices accessible for testing.1 device was 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.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
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.Section h codes have been updated to reflect this.Initially it was reported that there were 2 instances of this hazard/model number combination.Further review of records identified that one record was a duplicate.The number of occurrences summarized have been updated to reflect this.
Event or Problem Description
This report now summarizes 76 malfunction events, instead of 77.

• 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: 21911556
• Report Number: 0001831750-2025-00426
• Device Sequence Number: 17905307
• Product Code: FPO
• UDI-Device Identifier: 07613327278330
• UDI-Public: 07613327278330
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 76
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 06/12/2025
• 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