BEUDAMED
    FDA Adverse Event Death Summary report: N

    CADENCE ZOLL ADULT RTS

    MDR report key: 1226003 · Received November 6, 2008

    Report

    Report Number
    1219103-2008-00006
    Event Type
    Death
    Date Received
    November 6, 2008
    Report Date
    October 28, 2008
    Manufacturer
    COVIDIEN
    Product Code
    MLN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 10/28/08 THAT A CUSTOMER HAD AN ISSUE WITH A DEFIBRILLATION PAD. THE CUSTOMER STATED "PEDIATRIC PT RECEVING CPR. MULTI-FUNCTION DEFIBRILLATOR PADS WHEN SEPARATED FROM THE PLASTIC LINER, LEFT THE GEL MATERIAL ADHERING TO PLASTIC LINER. THE GEL MATERIAL DID NOT REMAIN ATTACHED TO THE ACTUAL ELECTRODE. PER RPTR, THERE WAS A DELAY OF PROCEDURE LASTING 20 MINUTES DUE TO THIS ISSUE. THEY THEN SWITCHED THE PADS TO A COMPETITOR'S PRODUCT AND THE PT WAS REVIVED. THE PT LATER CODED AND EXPIRED. RPTR STATED THAT THE PT DEATH HAD NOTHING TO DO WITH THE EARLIER CODE AND PROBLEM WITH THE ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADENCE ZOLL ADULT RTS DEFIBRILLATOR PADS MLN COVIDIEN 22770R 631467

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death