BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY GAMMA PATIENT MONITOR

    MDR report key: 1003226 · Received February 25, 2008

    Report

    Report Number
    1220063-2008-00006
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    January 17, 2008
    Report Date
    February 25, 2008
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INITIAL EVALUATION INDICATES A BATTERY PROBLEM WITH THE PATIENT MONITOR. WE ARE IN PROCESS OF FURTHER INVESTIGATING THE PROBLEM FOR THE ROOT CAUSE. WE EXPECT THE INVESTIGATION TO BE COMPLETED BY MARCH 21, 2008. WE WILL REPORT THE RESULT OF OUR INVESTIGATION, THE CAUSE OF THE PRODUCT MALFUNCTION, AND THE CORRECTIVE ACTION TO FDA BY MARCH 31, 2008.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A GAMMA PATIENT MONITOR WAS CONNECTED TO A PATIENT AND PLUGGED INTO WALL GPO VIA POWER PACK. AFTER 30 MINUTES OF USE THE CLINICAL STAFF NOTICED A BURNING SMELL COMING FROM THE MONITOR. MONITOR WAS TAKEN OFF PATIENT AND UNPLUGGED FROM WALL. INSPECTION OF THE MONITOR BY THE HOSPITAL BIOMED SHOWED THAT THE INTERNAL BATTERY HAD STARTED TO MELT CAUSING EXTENSIVE DAMAGE TO THE PLASTIC CASE OF THE MONITOR AND PLASTIC HOUSING OF THE BATTERY ITSELF. MONITOR, POWER SUPPLY AND BATTERY WERE SUPPLIED TO THE HOSPITAL IN MAY 2006. AS A PRECAUTION, ALL DRAGER GAMMA MONITORS AT THE HOSPITAL WERE INSPECTED AND AT THIS STAGE SHOW NO SIGNS OF ANY SIMILAR OVERHEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY GAMMA PATIENT MONITOR PATIENT MONITOR DRT DRAEGER MEDICAL SYSTEMS, INC. MS15481

    Patients

    Seq Age Sex Outcome Treatment
    1