BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLID GEL MFE, ADULT

    MDR report key: 222213 · Received May 5, 1999

    Report

    Report Number
    1220908-1999-00358
    Event Type
    Death
    Date Received
    May 5, 1999
    Report Date
    April 15, 1999
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING THE EMERGENCY ROOM PHYSICIAN'S ATTEMPT TO PACE A PT (AGE AND GENDER UNKNOWN) WHO WAS IN A CODE SITUATION, THE MULTI-FUNCTION ELECTRODES DID NOT APPEAR TO BE DELIVERING THE PACING PULSES TO THE PT. ALTHOUGH THE ZOLL PD1400 DEFIBRILLATOR (SERIAL NUMBER UNKNOWN) WAS SHOWING PACER MARKS ON THE SCREEN, THE PT DID NOT APPEAR TO BE RECEIVING THE PACING PULSES, AS THERE WAS NO HEART RATE CAPTURE AND THE PT DID NOT EXHIBIT ANY CHEST WALL OR THORACIC ACTIVITY. THE PHYSICIAN WAS ABLE TO OBTAIN ANOTHER DEVICE AND ELECTRODES TO PACE THE PT. THE COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED. PLEASE REFERENCE MEDWATCH NUMBERS 1220908-1999-00342 AND 1220908-1999-00357, WHICH DOCUMENT TWO DIFFERENT AND SUBSEQUENT EVENTS THAT OCCURRED WITH ELECTRODES FROM THE SAME MULTI-FUNCTION ELECTRODE LOT NUMBER OF 5198, BUT THAT WERE BEING USED ON DIFFERENT PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLID GEL MFE, ADULT Implant DEFIB/PACING ELECTRODE MLN ZOLL MEDICAL CORP. 89004000 5198

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death