BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADENCE ZOLL PRECONNECT

    MDR report key: 2200911 · Received June 30, 2011

    Report

    Report Number
    1219103-2011-00003
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 4, 2011
    Manufacturer
    COVIDIEN
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(6) 2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULT WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A PAIR OF DEFIBRILLATION PADS. THE CUSTOMER REPORTS THAT WHEN THE DOCTORS ATTEMPTED TO DEFIBRILLATE, THE PADS DID NOT SHOCK THE PT. THEY USED ANOTHER DEFIBRILLATOR BUT IT DID NOT WORK. THEY THEN USED ANOTHER PAIR OF DEFIBRILLATION PADS AND THIS TIME IT WORKED AND SHOCKED THE PT. THE PT EXPIRED, BUT THE CUSTOMER STATED THAT THERE IS NO CORRELATION BETWEEN THE PADS NOT WORKING AND THE PT DEATH. THE DEFIBRILLATOR WAS TESTED THE NEXT DAY BY THE CUSTOMER AND IT PASSED ALL TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADENCE ZOLL PRECONNECT DEFIBRILLATION PADS MLN COVIDIEN 22770PC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK