BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA

    MDR report key: 888247 · Received July 31, 2007

    Report

    Report Number
    1220063-2007-00018
    Event Type
    Malfunction
    Date Received
    July 31, 2007
    Date of Event
    July 12, 2007
    Report Date
    July 23, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. RECEIVED INFORMATION THAT ONE OF OUR DELTA PATIENT MONITORS WAS REPORTED TO HAVE MALFUNCTIONED DURING AN ELECTROSURGICAL PROCEDURE. THE CUSTOMER INDICATED THAT DURING SURGERY THE MONITOR WAS CONNECTED TO A DRAEGER LEAD SET WITH AN ESU BLOCK CONNECTED, WHICH IS USED TO FILTER ELECTRICAL DISTURBANCES CAUSED BY OTHER DEVICES. IT WAS REPORTED THAT DURING SURGERY THE CITED PATIENT WAS BEING MONITORED FOR SA02 AND ECG PARAMETERS WHEN THE DELTA MONITOR ALARMED FOR A BRADYCARDIA (LOW HEART RATE). BASED ON THIS ALARM, THE PATIENT WAS GIVEN "ATROPINE" TO TREAT THE LOW HEART RATE CONDITION, WHICH WAS REPORTED TO BE THE RESULT OF A FALSE ECG ALARM THAT WAS CAUSED BY ELECTRICAL INTERFERENCE AT THE PATIENT MONITOR. THE CUSTOMER ALSO INDICATED THAT WHEN THE ESU BLOCK (FILTER) WAS REMOVED FROM THE MONITORING SYSTEM, THE ECG WAS NORMAL AND SURGERY CONTINUED WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA DELTA PATIENT MONITOR DSI DRAEGER MEDICAL SYSTEMS, INC. NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other