BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    PRIME5TH/WHEEL ELECT STRETCHER

    MDR report key: 8835627 · Received July 29, 2019

    Report

    Report Number
    0001831750-2019-00614
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Date of Event
    April 1, 2019
    Report Date
    December 9, 2019
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    UDI-DI
    07613327278279
    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 FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THE DEVICE WAS EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED; THERE WERE BROKEN/DAMAGED COMPONENTS. THE DEVICE WAS REPAIRED AND RETURNED.

    Additional Manufacturer Narrative · 1

    THIS MDR IS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THE DEVICE IS PENDING EVALUATION.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE BRAKES WOULD NOT ENGAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE BRAKES WOULD NOT ENGAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630953 PRIME5TH/WHEEL ELECT STRETCHER STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 07613327278279

    Patients

    Seq Age Sex Outcome Treatment
    1