BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MEDICAL SYSTEMS MX8000IDT SCANNER

    MDR report key: 947048 · Received November 8, 2007

    Report

    Report Number
    1525965-2007-00030
    Event Type
    Malfunction
    Date Received
    November 8, 2007
    Date of Event
    April 25, 2007
    Report Date
    April 25, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Removal / Correction Number
    1525962-09/04/07-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TEAL HAS UL ELECTRICAL SAFETY APPROVAL, AND THE RISK OF INJURY TO A PATIENT IS REMOTE. THIS ISSUE WAS FOUND DURING THE REVIEW OF INTERNAL SERVICE RECORDS. VOLUNTARY MEDICAL DEVICE RECALL REPORT WAS FILED. IT IS A CLASS 2 RECALL. PMS ISSUED A FIELD CHANGE ORDER TO CORRECT THIS ISSUE IN MAY, 2007. THIS FCO HAS BEEN CHANGED TO MANDATORY ACTION TO ENSURE AGREEMENT WITH THE C&R REPORT. THE ROOT CAUSE OF THE ISSUE IS A COMPONENT FAILURE ON THE VENDED DEVICE.

    Description of Event or Problem · 1

    BASED ON INFORMATION THAT PMS RECEIVED ON 10/11/2007, PMS HAS DETERMINED THAT THIS REPORT IS SIMILAR TO OTHER MDR REPORTABLE EVENTS INVOLVING THE TEAL. HERE IS A SUMMARY OF THE ISSUE. THE USER REPORTED AN: ELECTRIC SMELL NEAR THE CONSOLE. GANTRY IS SPARKING. THE INITIAL REPORT DID NOT DOCUMENT THAT THE TEAL PDU WAS CAUSING THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEMS MX8000IDT SCANNER COMPUTER TOMOGRAPHY SCANNER JAK PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 YR