BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    PRIME 5TH WHEEL STRETCHER 26IN

    MDR report key: 15106905 · Received July 26, 2022

    Report

    Report Number
    0001831750-2022-00690
    Event Type
    Malfunction
    Date Received
    July 26, 2022
    Date of Event
    April 1, 2022
    Report Date
    September 12, 2022
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    UDI-DI
    07613327278149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Additional Manufacturer Narrative · 0

    UPON COMPLETION OF THE INVESTIGATION ON ONE OF THE DEVICES; IT WAS DETERMINED THAT IT WAS EXPERIENCING AN ADDITIONAL HAZARD OF FLUID LEAKS ONTO THE FLOOR. THE COUNT OF EVENTS HAS BEEN CORRECTED TO REFLECT THIS, AND THIS EVENT HAS NOW BEEN REPORTED UNDER MFR REPORT #0001831750-2022-00915.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED A SIDERAIL FALSE LATCH. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 0 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED A SIDERAIL FALSE LATCH. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708504 PRIME 5TH WHEEL STRETCHER 26IN STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1105 07613327278149

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown