BEUDAMED
    FDA Adverse Event Other Summary report: N

    DATASCOPE

    MDR report key: 617280 · Received June 10, 2005

    Report

    Report Number
    617280
    Event Type
    Other
    Date Received
    June 10, 2005
    Date of Event
    May 19, 2005
    Report Date
    June 7, 2005
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    GYE
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DATASCOPE TELEMETRY MONITORS WERE SWITCHED ON PATIENTS IN ROOM FOR 14 HOURS. THE ERROR WAS DISCOVERED WHEN ONE OF THE PATIENTS WAS DISCHARGED. THE MONITOR STRIP SHOWED FLUTTER FOR A PATIENT IN NORMAL SINUS AND VICE VERSA. THE PATIENT WITH FLUTTER DID NOT RECEIVE ANY TREATMENT. THE CARDIOLOGIST WAS MADE AWARE MONITORS WERE SWITCHED ON PATIENTS AND THE CORRECT READINGS WERE PROVIDED. THERE WAS NO HARM NOTED TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATASCOPE CARDIAC TELEMETRY GYE DATASCOPE CORPORATION UNK UNK
    2 DATASCOPE TELEMETRY MONITOR GYE DATASCOPE CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR
    2 73 YR