BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PACER

    MDR report key: 91614 · Received August 5, 1994

    Report

    Report Number
    91614
    Event Type
    Malfunction
    Date Received
    August 5, 1994
    Date of Event
    April 1, 1994
    Report Date
    May 6, 1994
    Manufacturer
    PHYSIO-CONTROL CORP.
    Product Code
    DTE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT BROUGHT INTO E.D. IN FULL CODE-IDIOVENTRICULAR/EMO RHYTHM. ATTEMPTED EXTERNAL PACEMAKER-PACER WOULD NOT WORK. PT EXPIRED. FINAL DIAGNOSIS WAS FATAL CARDIAC DYSRHYTHMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL PACER * DTE PHYSIO-CONTROL CORP. 80290404, 802700-07 *
    2 LIFE PAC-8 * LDD PHYSIO-CONTROL CORP. 802700-07 *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR