BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYDIAGNOST ELEVA DRF

    MDR report key: 6120868 · Received November 22, 2016

    Report

    Report Number
    3003768251-2016-00009
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Report Date
    October 28, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    KPR
    PMA / PMN Number
    K031535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EASYDIAGNOST SYSTEM IS EQUIPPED WITH A MOBILE HOLDER (TROLLEY) FOR THE WIRELESS PORTABLE DETECTOR. THE MOBILE HOLDER IS DESIGNED TO TAKE FULL ADVANTAGE OF THE WIRELESS PORTABLE DETECTOR TO PERFORM FREE EXPOSURES IN OPTIMAL CONDITIONS. THE DEFECT TROLLEY WAS SENT BACK TO MANUFACTURER FOR INVESTIGATION. THE INVESTIGATION RESULTS IN A MODIFICATION OF THE DETECTOR CLAMPING MECHANISM. PHILIPS RECALL #: FCO71200174.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING APPLICATION TRAINING THE WIRELESS PORTABLE DETECTOR HAS DROPPED DOWN FROM THE TROLLEY DURING CHANGE OF THE DETECTOR POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774269 EASYDIAGNOST ELEVA DRF SYSTEM, X-RAY, STATIONARY KPR PHILIPS MEDICAL SYSTEMS DMC GMBH 706050

    Patients

    Seq Age Sex Outcome Treatment
    1