BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITALDIAGNOST DUAL DETECTOR

    MDR report key: 4092870 · Received August 21, 2014

    Report

    Report Number
    3003768251-2014-00012
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Report Date
    July 23, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    MQB
    PMA / PMN Number
    K982795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER CHECKED THE SYSTEM AND VERIFIED THAT THE FOOT PLATE CANNOT FALL DOWN, IF THE PLASTIC HOOK IS CLICKED FULLY INTO THE TRANSPORT POSITION, AS DESCRIBED IN THE FIELD SAFETY NOTE. THE CUSTOMER WAS INFORMED VIA A FIELD SAFETY NOTE TO CHECK ALWAYS THE RIGHT POSITION OF THE HOOK AND THAT THE HOOK IS LOCKED. THIS IS A KNOWN PROBLEM AND HAS RESULTED IN A CLASS 2 RECALL WHICH WAS REPORTED TO FDA. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT FROM A CUSTOMER THAT A PATIENT STEP PLATE OF THE STITCHING SUPPORT IS NO LONGER BEING HELD CORRECTLY IN UPRIGHT POSITION DURING TRANSPORT. THE LOCKING HOOK FOR THE FOOTBOARDS UPRIGHT POSITION DOES NOT RELIABLY REACH ITS SAVE LOCK POSITION AUTOMATICALLY ANYMORE. DEFECTIVE HINGES HAVE BEEN IDENTIFIED AND REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504515 DIGITALDIAGNOST DUAL DETECTOR MQB PHILIPS MEDICAL SYSTEMS DMC GMBH 712022

    Patients

    Seq Age Sex Outcome Treatment
    1