BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARRHYTHMIA MONITORING SOFTWARE

    MDR report key: 21176 · Received April 14, 1995

    Report

    Report Number
    MW1005602
    Event Type
    Injury
    Date Received
    April 14, 1995
    Date of Event
    February 14, 1995
    Report Date
    March 29, 1995
    Manufacturer
    HEWLETT-PACKARD CO.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 2/14/95 PT WENT INTO V-FIB. SYSTEM ALARMED CORRECTLY. PT HAS AICD WHICH CONVERTED THE V-FIB. THE PT WENT BACK INTO V-FIB AND THE SYSTEM DID NOT ALARM. THE BEAT LABELS WERE INAPPROPRIATE. THE SOFTWARE DID NOT CORRECTLY LABEL THE V-FIB AND TORSADE BEATS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRHYTHMIA MONITORING SOFTWARE ARRHYTHMIA MONITORING SOFTWARE DRT HEWLETT-PACKARD CO. M2360A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening