BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MX 8000 IDT

    MDR report key: 1760393 · Received July 8, 2010

    Report

    Report Number
    1525965-2010-00013
    Event Type
    Injury
    Date Received
    July 8, 2010
    Date of Event
    January 5, 2010
    Report Date
    June 8, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO SUGGESTS THAT THE SITE WAS AWARE THAT THE CT SYSTEM WAS OUT OF SERVICE BEFORE THE PT WAS ADMITTED, AND IT APPEARS THAT THE SITE DID NOT HAVE ALTERNATIVE ARRANGEMENTS TO AVOID DELAY IN DIAGNOSIS, OR ADVERSE EFFECT ON TREATMENT. (B)(4). (B)(6)

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE 7-YEAR OLD CT SYSTEM WAS UNAVAILABLE DUE TO A FAULT ON THE VERTICAL MOTION OF THE PT TABLE, CAUSING ALL SYSTEM MOTIONS TO BE DISABLED. THE FSE WAS ABLE TO DIAGNOSE THE PROBLEM AND ORDERED REPLACEMENT PARTS. IN THE MEANTIME, THE FSE WAS ABLE TO BRING THE SYSTEM BACK ON LINE TEMPORARILY WHILE WAITING FOR THE REPLACEMENT PARTS TO ARRIVE, HOWEVER, THIS TEMPORARY CONDITION ONLY LASTED FOR 2 HOURS AND 45 MINUTES WHEN THE SYSTEM EXPERIENCE THE FAULT AGAIN. AFTER THE SYSTEM WENT DOWN, A TRAUMA PT WAS CONSIDERED TO REQUIRE A CT SCAN; HOWEVER, THE CT SCANNER WAS NOT FUNCTIONING AT THAT TIME. THIS RESULTED IN A DELAY OF DIAGNOSIS OF ACUTE EXTRADURAL BLEED. THE SITE THEN SUBMITTED A SERIOUS ADVERSE INCIDENT FORM TO THE (B)(4). ON (B)(6)2010, THE (B)(6) CONTACTED PHILIPS REQUESTING INFO ABOUT THIS INCIDENT (B)(4). THERE IS NO INDICATION THAT THERE WAS AN ADVERSE OUTCOME AS A RESULT OF THE DELAY IN DIAGNOSIS. OUTCOME OF THE PT IS UNK. THIS MDR IS BEING FILED IN THE EVENT THAT THE UNAVAILABILITY OF THE CT SYSTEM CAUSED A DELAY IN DIAGNOSIS, WHICH IN TURN COULD HAVE CAUSED A DELAY IN TREATMENT, WHICH COULD HAVE RESULTED IN AN ADVERSE EFFECT ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MX 8000 IDT JAK/CT JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1