BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1027 TRAUMA STRETCHER

    MDR report key: 2304529 · Received November 19, 2007

    Report

    Report Number
    1419182-2007-00001
    Event Type
    Malfunction
    Date Received
    November 19, 2007
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE PURCHASED STRETCHER BASES FROM STRYKER MEDICAL CORP. AND COMBINE IT WITH OUR TOP TO MAKE A CART THAT IS USED FOR SHOWER BATHING HOSPITAL PTS. (B)(6), 2007 STRYKER CORP. SENT TO US A MEDICAL DEVICE CORRECTION NOTICE. THE NOTICED STATED THAT THE BRAKE CAMS CAN CRACK DURING THE ENGAGEMENT OF THE BRAKES CAUSING THE BRAKES TO MALFUNCTION, AND THAT A BUSHING WAS WEARING EXCESSIVELY. (B)(4). BY MERIT OF THE MEDICAL DEVICE CORRECTION NOTICE, THE SUMMARY IS TO REPLACE THE BRAKE CAMS AND BUSHINGS.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1027 TRAUMA STRETCHER FPO STRYKER MEDICAL 0722000000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1