BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM104 M-SERIES W/5TH WHEEL

    MDR report key: 2981427 · Received February 27, 2013

    Report

    Report Number
    0001831750-2013-01570
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPAIR WORK ORDER THAT THE PATIENT-LEFT SIDE RAIL WOULD NOT LATCH IN THE UPRIGHT POSITION DUE TO A BROKEN SPINDLE SPACER. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84108 SM104 M-SERIES W/5TH WHEEL STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1007

    Patients

    Seq Age Sex Outcome Treatment
    1