BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLAR 8000M MONITOR

    MDR report key: 2153482 · Received June 21, 2011

    Report

    Report Number
    2124823-2011-00098
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 21, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K993757
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPARKING SOUND WAS OBSERVED FROM INSIDE THE SOLAR 8000M MONITOR. UPON INVESTIGATION IT WAS DETERMINED THAT THE CPU WAS DEFECTIVE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. 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 SOLAR 8000M MONITOR PHYSIOLOGICAL PATIENT MONITOR DSI GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1