BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINICAL INFORMATION CENTER

    MDR report key: 2099536 · Received May 13, 2011

    Report

    Report Number
    2124823-2011-00077
    Event Type
    Other
    Date Received
    May 13, 2011
    Date of Event
    March 19, 2011
    Report Date
    May 13, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K032370
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN ASYSTOLE ARRHYTHMIA AND THE CLINICAL INFORMATION CENTER (CIC) DEVICE ALLEGEDLY DID NOT PROVIDE AN ALARM. INITIAL GE HEALTHCARE DEVICE LOG REVIEW INDICATES THAT THE SYSTEM WAS OPERATING AS DESIGNED AND THAT USE ERROR MAY HAVE BEEN A FACTOR. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL INFORMATION CENTER CENTRAL STATION DSI GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other