BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM104 M-SERIES W/5TH WHEEL

    MDR report key: 3020317 · Received March 25, 2013

    Report

    Report Number
    0001831750-2013-02487
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS FOUND THAT THE PATIENT LEFT SIDE RAIL WAS NOT LATCHING UP DUE TO A BROKEN SPINDLE SPACER AND BROKEN TOP RAIL AT SPINDLE MOUNT FLANGE. EXPOSED SHARP EDGES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDERAIL WILL NOT LATCH DUE TO BROKEN LATCH SPINDLE AND TOPRAIL. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDERAIL WILL NOT LATCH DUE TO BROKEN LATCH SPINDLE AND TOPRAIL. 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
    121518 SM104 M-SERIES W/5TH WHEEL STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1