BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SC6002

    MDR report key: 964976 · Received December 14, 2007

    Report

    Report Number
    1220063-2007-00043
    Event Type
    Malfunction
    Date Received
    December 14, 2007
    Date of Event
    November 12, 2007
    Report Date
    December 12, 2007
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE REQUESTED THE ELECTRONIC DEVICE LOGS.

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. HAS RECEIVED INFO FROM A CUSTOMER THAT A DELAY IN A ALARM OCCURRED WHILE MONITORING A PT'S NBP. THE CUSTOMER REPORTED THAT THE AUDIBLE ALARM NOTIFICATION OF AN ELEVATED BLOOD PRESSURE VALUE OF A PT DID OCCUR, BUT THEY FELT THAT THE ALARM ANNUNCIATION WAS NOT TIMELY. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SC6002 PATIENT MONITOR DRT DRAGER MEDICAL SYSTEMS, INC. (IT/M) SC6002

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR