BEUDAMED
    FDA Adverse Event Other Summary report: N

    MOBILETT XP

    MDR report key: 1670583 · Received April 27, 2010

    Report

    Report Number
    2240869-2010-00008
    Event Type
    Other
    Date Received
    April 27, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 22, 2010
    Manufacturer
    SIEMENS AG
    Product Code
    IZL
    PMA / PMN Number
    K033238
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TO THE BEST OF OUR KNOWLEDGE, THE USER'S HEARING PROBLEMS WERE TEMPORARY. (B)(6)..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE SHOCK TREATMENT ROOM OF THE EMERGENCY UNIT, AN EXPLOSION OCCURRED ON A MOBILE RADIOLOGY DEVICE (MOBILETT XP) FROM SIEMENS. TWO USERS WERE NEXT TO THE SYSTEM, AND SUFFERED MOMENTARY HEARING PROBLEMS. THE EXPLOSION WAS IN THE CAPACITOR CHARGE CIRCUIT WHICH IS INTERNAL TO THE UNIT, AND WAS CONTAINED WITHIN THE CABINET OF THE UNIT. THE BIOMEDICAL SERVICE ASCERTAINED AFTER REMOVING THE COVERS THAT A 400-V CAPACITOR WAS EJECTED FROM AN ELECTRONIC CIRCUIT BOARD. THE BIOMEDICAL SERVICE CALLED (B)(6)., WHICH HOLDS THE AP-HP MAINTENANCE AGREEMENT. ACCORDING TO THE (B)(6). TECH, THE CAPACITOR CHARGE BOARD D952 WAS SHORT-CIRCUITED AND DAMAGED BOARD D972 (FUSES DESTROYED). THE TWO BOARDS REQUIRED REPLACEMENT. THIS EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBILETT XP SYSTEM, X-RAY, MOBILE IZL SIEMENS AG 1818363 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other