BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL INFORMATION CENTER

    MDR report key: 2192763 · Received July 20, 2011

    Report

    Report Number
    2124823-2011-00128
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 20, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K062976
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TELEMETRY MONITORING WAS LOST FOR APPROXIMATELY 80 PATIENTS DUE TO A FAILED UNINTERRUPTIBLE POWER SUPPLY (UPS). THE UPS FAILURE MAY BE ASSOCIATED WITH A STORM THAT WAS PASSING THROUGH AT THE TIME. THERE WAS NO DEATH OR SERIOUS INJURY REPORTED IN ASSOCIATED WITH THIS EVENT. IT IS NOT KNOWN IF GE HEALTHCARE PROVIDED THE UPS TO THE HOSPITAL. 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