BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED CORPORATION

    MDR report key: 3929720 · Received June 10, 2014

    Report

    Report Number
    3929720
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 30, 2014
    Manufacturer
    CONMED CORP
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EMS CREW WAS ON SCENE WITH PT WHO WAS IN FULL ARREST. CREW MEMBER TURNED THE MONITOR ON AND PLACED THE D-FIB PAD ON THE PT WAS THE OTHER CREW DID CPR. AFTER THE PADS WERE IN PLACE, IT WAS NOTED THAT THEY WERE NOT SHOWING A CONNECTION. THEY WERE UNPLUGGED AND PLUGGED BACK TOGETHER AND GOT CONNECTION BUT WHEN THE CREW MEMBER LET GO OF THE CONNECTION, THE CONNECTION WAS LOST. CREW MEMBER HELD THE PLUG TOGETHER AS THE PT WAS IN V-FIB, THE MONITOR WAS CHARGED AND DELIVERED A SHOCK. PT HAD THE NORMAL FULL BODY MUSCLE CONTRACTION, SO WE KNEW IT WORKED. A SECOND SET OF PADS WERE TAKEN OUT OF PACKAGING AND SAME TYPE OCCURRENCE-WOULD NOT STAY CONNECTED WITHOUT CREW MEMBER HOLDING THE CONNECTION TOGETHER. DURING THE COURSE OF THE CODE, THE PAD CONNECTOR WAS HELD TOGETHER WHEN NEEDED FOR D-FIB. THE PADS DID STAY CONNECTED ON THEIR OWN FOR SOME OF THE TIME BUT OTHER TIMES REQUIRED A CREW MEMBER TO HOLD THE CONNECTOR TOGETHER FOR A CONNECTION TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337333 CONMED CORPORATION DEFIBRILLATOR PADS, PRODUCT CODE: MKJ MKJ CONMED CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other