BEUDAMED
    FDA Adverse Event Summary report: N

    MONITOR/DEFIBRILLATOR

    MDR report key: 13637 · Received May 31, 1994

    Report

    Report Number
    MW1002279
    Date Received
    May 31, 1994
    Date of Event
    May 19, 1994
    Report Date
    May 20, 1994
    Manufacturer
    DATASCOPE CORP.
    Product Code
    LDD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RPTR WAS USING THE MONITOR/DEFIBRILLATOR TO CARDIOVERT A PT IN ATRIAL FLUTTER. THE MONITOR HAD BEEN WORKING APPROPRIATELY WITH A PAPER READOUT OF THE PATTERN. THE CARDIOVERSION AT 20 J WAS COMPLETED BY THE DR. THE PT REMAINED IN ATRIAL FLUTTER WHICH WAS NOTED TO BE THE SAME ON THE MONITOR. THE DR PERFORMED A SUCCESSFUL CARDIOVERSION AT 50 J TO NORMAL SINUS RHYTHM WITH FIRST DEGREE BLOCK. AFTER THE PROCEDURE, IT WAS NOTED THAT THE PAPER PRINTOUT OF THE HEART PATTERN WAS STRAIGHT-LINED AT THE FIRST SHOCK OF 20 J AND THE PATTERN CONTINUED TO BE SHOWN ON THE SCREEN. RPTR WAS UNABLE TO DO A SYNCHRONIZED TEST OF THE MONITOR AFTER THE PROCEDURE. IT IS POSSIBLE THE LEAD WIRES WERE INADVERTENTLY PLACED UNDER THE PADDLES "WITH THE SHOCKS." NO APPARENT INJURY TO PT. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONITOR/DEFIBRILLATOR MONITOR/DEFIBRILLATOR LDD DATASCOPE CORP. MD4

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR