BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM104 M-SERIES W/5TH WHEEL

    MDR report key: 3040579 · Received April 8, 2013

    Report

    Report Number
    0001831750-2013-02994
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES WOULD NOT ENGAGE DUE TO MISSING HEAD AND FOOT END ROLL PINS. IT WAS FURTHER FOUND THAT THE MATTRESS COULD NOT FULLY ADHERE TO THE LITTER SURFACE DUE TO THE VELCRO PILES MISSING. 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
    144171 SM104 M-SERIES W/5TH WHEEL STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1007

    Patients

    Seq Age Sex Outcome Treatment
    1