BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MX8000Q CT SCANNER

    MDR report key: 2992390 · Received March 1, 2013

    Report

    Report Number
    1525965-2013-00021
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 20, 2008
    Report Date
    February 20, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K982060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A RESULT OF A RETROSPECTIVE REVIEW OF PHILIPS HEALTHCARE COMPLAINTS BACK TO (B)(4) 2007. THE SYSTEM WAS EVALUATED BY THE FIELD SAFETY ENGINEER (FSE) AND DETERMINED THE ROOT CAUSE TO BE A FAILED MOTHER BOARD. THE SYS WAS REPAIRED AND RETURNED TO CLINICAL OPERATION. THE USER WAS INFORMED THAT THIS CABINET SHOULD ONLY BE OPENED BY QUALIFIED PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    PHILIPS REC'D INFO THAT AT A SITE THERE WAS A CIRCUIT BREAKER F9 CUT OFF AND THE OPERATOR EXPERIECED AN ELECTRIC SHOCK AND A LIGHT BURN ON LEFT HAND FINGERS WHEN OPENING THE POWER DISTRIBUTION CABINER (PDC). ADD'L INFO REC'D WAS THAT THE OPERATOR WAS EVALUATED IN THE EMERGENCY ROOM BUT NO OTHER MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89540 MX8000Q CT SCANNER NONE JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728201

    Patients

    Seq Age Sex Outcome Treatment
    1