BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICENTRAL

    MDR report key: 1963735 · Received December 22, 2010

    Report

    Report Number
    9610105-2010-00023
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    GE HEALTHCARE, FINLAND OY
    Product Code
    MSX
    PMA / PMN Number
    K052972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MFG DATE NOT AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED MONITORING MAY HAVE BEEN LOST FOR A NUMBER OF PTS. THERE WAS A REPORTED POWER FAILURE AND POSSIBLE "FAULT" THAT REQUIRED THE ICENTRAL (CENTRAL STATIONS) TO BE RECONFIGURED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICENTRAL PHYSIOLOGICAL PATIENT MONITOR-CENTRAL MSX GE HEALTHCARE, FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1