BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 3000766 · Received March 12, 2013

    Report

    Report Number
    0001831750-2013-01968
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUSLY, IT WAS REPORTED THAT THE UNIT WAS INTERMITTENTLY GOING INTO ZOOM DRIVE. HOWEVER, UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION IT WAS DETERMINED THAT THE UNIT WAS INTERMITTENTLY DISENGAGING FROM ZOOM DRIVE DUE TO FAULTY BATTERIES. ADDITIONALLY, THE PREVIOUS MDR INITIAL REPORT WAS ISSUED WITHOUT THE PMA/510(K)#. THIS FOLLOW-UP REPORT INCLUDES THE PMA/510(K)#.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE STRETCHER INTERMITTENTLY GOES INTO ZOOM DUE TO MALFUNCTINED BATTERIES. 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 STRETCHER INTERMITTENTLY GOES INTO ZOOM DUE TO MALFUNCTIONED BATTERIES. 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
    103131 SM304 M-SERIES W/ZOOM STRETCHER, WHEELED, POWERED INK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1