BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTIVIEW WORKSTATION W/TELEMETRY OPTION

    MDR report key: 601375 · Received May 9, 2005

    Report

    Report Number
    1220063-2005-00006
    Event Type
    Other
    Date Received
    May 9, 2005
    Date of Event
    April 7, 2005
    Report Date
    April 11, 2005
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A FULL ASYSTOLE EVENT IN 2005 AT 14:12:34 AND AGAIN 15:50:46. THE CUSTOMER STATED BOTH ASYSTOLE RHYTHMS WERE NOT RECOGNIZED BY THE TELEMETRY PATIENT MONITOR. THE CUSTOMER REPORTED THAT THE ONLY MESSAGE FOUND WAS AT THE CENTRAL MONITOR IN THE PATIENT FULL DISCLOSURE REPORT, (PAUSE REPORT), WHICH WAS RECORDED AT 14:12:40. THE CUSTOMER ALSO STATED THAT ESPECIALLY ON THE V LEAD IT IS CLEAR TO SEE THAT THE RHYTHM WAS AN ASYSTOLE. THE NURSES FOUND THIS PATIENT IN BED AND REPORTED THIS TO THE CCU WARD. THE CUSTOMER CLAIMED THAT THE PATIENT NEARLY DIED AND WAS GIVEN AN EXTERNAL PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIVIEW WORKSTATION W/TELEMETRY OPTION PATIENT MONITORING SYSTEM DRT DRAEGER MEDICAL SYSTEMS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Life Threatening