BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY VISTA

    MDR report key: 981182 · Received January 11, 2008

    Report

    Report Number
    1220063-2008-00001
    Event Type
    Malfunction
    Date Received
    January 11, 2008
    Date of Event
    December 14, 2007
    Report Date
    January 7, 2008
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE REQUESTED THE RETURN OF THE CITED MONITOR AND BATTERY FOR EVALUATION. RESULTS WILL BE INCLUDED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC HAS RECEIVED INFO FROM A CUSTOMER THAT ONE OF OUR MONITORS WAS FOUND WITH AN OVER HEATED INTERNAL BATTERY, BUT DID NOT EFFECT THE FUNCTIONALITY OF THE MONITOR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY VISTA BEDSIDE PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. (IT/M) MS14743 S/N 5514094865

    Patients

    Seq Age Sex Outcome Treatment
    1 NA