BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITALDIAGNOST DUAL DETECTOR

    MDR report key: 2925265 · Received January 17, 2013

    Report

    Report Number
    3003768251-2013-00001
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Report Date
    December 20, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    MQB
    PMA / PMN Number
    K982795
    Removal / Correction Number
    Z-2465-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION SHOWED THE LOCK MECHANISM AT THE WIRELESS DETECTOR MOBILE HOLDER HAS BEEN LOOSE. FOUR SCREWS ARE NOT FIXED PROPERLY. THE FIELD SERVICE ENGINEER SECURED THE 4 COUNTERSUNK SCREWS WITH THREAD LOCKE (LOCTITE 243). AFTER THE REPAIR, THE SYSTEM WORKS AS SPECIFIED. THE CORRECTION FOR THE "LOCK MECHANISM MOBILE WIRELESS PORTABLE DETECTOR HOLDER" IS IN PROGRESS FOR THE INSTALLED BASE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE CLAMP MECHANISM OF THE MOBILE HOLDER FOR THE WIRELESS PORTABLE DETECTOR (WPD) DOES NOT HOLD THE DETECTOR SECURELY. THE WPD FEEL DOWN DURING THE MOVEMENT OF THE MOBILE WPD HOLDER. THERE WAS NO ONE INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26453 DIGITALDIAGNOST DUAL DETECTOR MQB, KPR MQB PHILIPS MEDICAL SYSTEMS DMC GMBH 712022

    Patients

    Seq Age Sex Outcome Treatment
    1