BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSMART

    MDR report key: 2081135 · Received April 14, 2011

    Report

    Report Number
    2124823-2011-00041
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 16, 2011
    Report Date
    April 14, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    LOS
    PMA / PMN Number
    K973403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MONTH OF MANUFACTURE IS NOT KNOWN AT THIS TIME. THIS DEVICE WAS ORIGINALLY MANUFACTURED IN (B)(4) BUT THE FACILITY NO LONGER MANUFACTURES DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE WAS PERFORMING AN ELECTROCARDIOGRAPH (ECG) WHEN SHE SMELLED A FAINT BURNING SCENT. SHE WENT ON TO PERFORM 2 MORE ECGS AND THE SMELL INCREASED. THE UNIT WAS SWITCHED OFF AND A TECHNICIAN WAS CALLED TO CHECK THE DEVICE. THE TECHNICIAN TURNED TO UNIT BACK ON 5 MINUTES LATER AND NOTICED VISIBLE SMOKE COMING FROM THE DEVICE. THE UNIT WAS SWITCHED OFF AND THE BATTERY REMOVED. THE BATTERY WAS REPORTED TO BE NEAR ROOM TEMPERATURE. AFTER A FEW MINUTES, A BLISTER FORMED ON THE PLASTIC HOUSING NEAR THE ECG CABLE CONNECTION. THE BLISTER DEVELOPED INTO A BLACKENED HOLE. THE UNIT'S MOTHERBOARD WAS VISIBLY HOT. THERE WERE NO INJURIES REPORTED. 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 MICROSMART ECG ANALYSIS SYSTEM LOS GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1