BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    PRIME 5TH WHEEL STRETCHER 30IN

    MDR report key: 11238934 · Received January 27, 2021

    Report

    Report Number
    0001831750-2021-00311
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    October 1, 2020
    Report Date
    April 5, 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 · 0

    UPON INSPECTION OF ONE OF THE DEVICES IT WAS DETERMINED ONE OF THE PEDALS WERE INOPERABLE REQUIRING THE USE OF AN ALTERNATE PEDAL, WHICH IS NOT REPORTABLE.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THERE WAS REDUCED/INADEQUATE BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 1 DEVICE WAS NOT INSPECTED, AS THE ISSUE WAS IDENTIFIED AND RESOLVED DURING A TROUBLESHOOTING CALL BETWEEN THE CUSTOMER AND STRYKER TECHNICAL SUPPORT. 1 DEVICE IS PENDING INVESTIGATION. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THERE WAS REDUCED/INADEQUATE BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132845 PRIME 5TH WHEEL STRETCHER 30IN STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1105 07613327278156

    Patients

    Seq Age Sex Outcome Treatment
    1