BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME BIG WHEEL STRETCHER 30"

    MDR report key: 20579394 · Received October 31, 2024

    Report

    Report Number
    0001831750-2024-01388
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 2, 2024
    Report Date
    November 7, 2024
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    UDI-DI
    07613327278330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN ACCORDANCE WITH THE ¿FINAL GUIDANCE ON MEDICAL DEVICE REPORTING FOR MANUFACTURERS¿ ISSUED ON NOVEMBER 7, 2016, STRYKER MEDICAL WILL NO LONGER REPORT THE HAZARD OF BRAKES WON¿T ENGAGE; FALSE ENGAGEMENT OF BRAKES FOR OUR STRETCHER LINES (PRODUCT CODE FPO), AS THIS HAZARD HAS NOT CAUSED OR CONTRIBUTED TO ANY SERIOUS INJURIES IN AT LEAST TWO YEARS. THE LAST SERIOUS ADVERSE EVENT MANUFACTURER REPORT #0001831750-2017-00421 WAS ORIGINALLY SUBMITTED ON SEPTEMBER 27TH, 2017. WHILE NO NEW MDRS WILL BE GENERATED FOR THIS HAZARD MOVING FORWARD, ADDITIONAL SUPPLEMENTAL RECORDS MAY BE SUBMITTED FOR PAST REPORTED EVENTS IF NEW INFORMATION BECOMES AVAILABLE. SHOULD A NEW SERIOUS ADVERSE EVENT OCCUR ATTRIBUTED TO THIS HAZARD, MDR REPORTING WILL RESUME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BIG WHEEL LINKAGE WAS BROKEN WHICH CAN CAUSE THE BRAKES TO NOT BE ENGAGED; FALSE ENGAGEMENT OF BRAKES. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BIG WHEEL LINKAGE WAS BROKEN WHICH CAN CAUSE THE BRAKES TO NOT BE ENGAGED; FALSE ENGAGEMENT OF BRAKES. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848810 PRIME BIG WHEEL STRETCHER 30" STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 07613327278330

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown