BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITALDIAGNOST SINGLE DETECTOR

    MDR report key: 3338962 · Received August 22, 2013

    Report

    Report Number
    3003768251-2013-00004
    Event Type
    Malfunction
    Date Received
    August 22, 2013
    Report Date
    July 25, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS GMBH DMC,
    Product Code
    MQB
    PMA / PMN Number
    K982895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP WILL SENT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER HAS REPORTED THAT THE FOOTPLATE HOOK OF THE STITCHING PT SUPPORT (STAND) WAS DEFECT. THE FOOTPLATE HOOK WILL BE USED TO SECURE THE FOOTPLATE IN CASE THE OPERATOR HAS TO MOVE THE STITCHING PT SUPPORT. THE OPERATOR HAS RECOGNIZED WHEN IT WAS NOT IN CLINICAL USE. THERE WAS NO ONE HURT IN THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408379 DIGITALDIAGNOST SINGLE DETECTOR MQB, KPR MQB PHILIPS MEDICAL SYSTEMS GMBH DMC, 712020

    Patients

    Seq Age Sex Outcome Treatment
    1