BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    PRIME 5TH WHEEL STRETCHER 30IN

    MDR report key: 11238788 · Received January 27, 2021

    Report

    Report Number
    0001831750-2021-00310
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    October 1, 2020
    Report Date
    January 27, 2021
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    UDI-DI
    07613327278156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 2 DEVICES WERE FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THESE DEVICES WERE REPAIRED AND RETURNED TO USE. 1 DEVICE WAS INSPECTED BY THE USER FACILITY AND THE ISSUE WAS CONFIRMED. THE DEVICE WAS DAMAGED BEYOND REPAIR AND REMOVED FROM SERVICE. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE BRAKES WERE DIFFICULT TO ENGAGE/DISENGAGE OR THE STEER MECHANISM WAS DIFFICULT TO ENGAGE/DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133523 PRIME 5TH WHEEL STRETCHER 30IN STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1105 07613327278156

    Patients

    Seq Age Sex Outcome Treatment
    1