BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S/5 CRITICAL CARE MONITOR

    MDR report key: 1362534 · Received March 24, 2009

    Report

    Report Number
    9610105-2009-00013
    Event Type
    Malfunction
    Date Received
    March 24, 2009
    Date of Event
    July 14, 2008
    Report Date
    March 24, 2009
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    MHX
    PMA / PMN Number
    K071889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (6) PRIVACY LAW PROHIBITS RELEASING PATIENT INFORMATION. GE HEALTHCARE INVESTIGATED THE NMF CPU MOTHERBOARD AND F-CPU POWER BOARD. BOTH BOARDS WERE BADLY BURNED. AS A RESULT, THE BOARDS WERE UNABLE TO BE REPAIRED OR TESTED. VISUAL INSPECTION REVEALED THAT A CAPACITOR AND PRINTED CIRCUIT BOARD AT THE SAME LOCATION BENEATH THE CAPACITOR WAS BURNED, RESULTING IN A HOLE IN THE PRINTED CIRCUIT BOARD ON THE NMF CPU MOTHERBOARD. SEVERAL COMPONENTS WERE BURNED ON THE F-CPU POWER BOARD, RESULTING IN A HOLE IN THE PRINTED CIRCUIT BOARD AS WELL. DUE TO THE EXTENT OF THE DAMAGE TO BOTH BOARDS, THE ROOT CAUSE FOR THE COMPONENT FAILURES REMAINS UNKNOWN, AS NEITHER BOARD COULD BE TESTED. THE DEFECTIVE BOARDS WERE REPLACED AND THE MONITOR WAS PLACED BACK INTO USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PARTS OF THE POWER BOARD AND CPU MOTHERBOARD FAILED ON THE S/5 CRITICAL CARE MONITOR, RESULTING IN A LOSS OF MONITORING WITHOUT AN ALARM. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S/5 CRITICAL CARE MONITOR MODULAR MONITORS MHX GE HEALTHCARE FINLAND OY S/5 CCM

    Patients

    Seq Age Sex Outcome Treatment
    1