BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    5TH WHEEL STRETCHER, PRIME X

    MDR report key: 7453095 · Received April 23, 2018

    Report

    Report Number
    0001831750-2018-00247
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    December 2, 2017
    Report Date
    April 23, 2018
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    UDI-DI
    07613327278194
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS PART OF THE MALFUNCTION SUMMARY REPORTING PROGRAM, EXEMPTION NUMBER E2014007. THE DEVICE WAS EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED. THE DEVICE HAD A DAMAGED COMPONENT. THERE WERE NO REMEDIAL ACTIONS TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE BRAKES WOULD NOT ENGAGE. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294595 5TH WHEEL STRETCHER, PRIME X STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 07613327278194

    Patients

    Seq Age Sex Outcome Treatment
    1