BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 3140284 · Received May 31, 2013

    Report

    Report Number
    0001831750-2013-04932
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE ZOOM DRIVE WOULD DISENGAGE DURING USE DUE TO A DAMAGED LOAD CELL WELDMENT. HOWEVER, THE UNIT WOULD STILL BE MOBILE MANUALLY. ADDITIONALLY, THE SCALE WAS PROVIDING AN INACCURATE READING DUE TO A MALFUNCTIONED SCALE DISPLAY ASSEMBLY. 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
    242424 SM304 M-SERIES W/ZOOM STRETCHER, WHEELED, POWERED INK STRYKER MEDICAL-KALAMAZOO 1025

    Patients

    Seq Age Sex Outcome Treatment
    1