BEUDAMED
    FDA Adverse Event Other Summary report: N

    1310P MEDITRACE 2/PK 20/CA

    MDR report key: 2577647 · Received May 11, 2012

    Report

    Report Number
    9681860-2012-00003
    Event Type
    Other
    Date Received
    May 11, 2012
    Date of Event
    March 28, 2012
    Report Date
    April 19, 2012
    Manufacturer
    COVIDIEN
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    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 04/19/2012 THAT A CUSTOMER HAD AN ISSUE WITH A DEFIBRILLATION ELECTRODE. THE CUSTOMER REPORTS THAT THE (B)(6) FIRE AND AMBULANCE REPORTED THAT THE ELECTRODES FAILED TO DELIVER SHOCK DURING A TREATMENT WHEN THEY RESPONDED TO A CARDIAC ARREST. THE CUSTOMER FURTHER REPORTED THAT DURING THE TREATMENT, A PHYSIO-CONTROL LP-12 DEFIBRILLATOR WAS USED WITH A COVIDIEN MEDITRACE ELECTRODE AND 5 DEFIBRILLATIONS AT 200J, 300J, 360J, 360J AND 360J WERE ATTEMPTED. THE (B)(6) STATED THAT THE SEQUENCES WERE ALL DONE WITHIN A 60 SECOND WINDOW, AND THE ELECTRODES WERE NOT DISCONNECTED FROM THE MONITOR. THE CUSTOMER FURTHER REPORTED THAT UPON PRINTING THE CODE SUMMARY, IT WAS NOTED THAT ONLY THE LAST 360J DEFIBRILLATION SHOCK WAS DELIVERED. THE PT WAS CONVERTED AT A LOCAL HOSPITAL AND WAS THEN TRANSPORTED TO (B)(6) HOSPITAL WHERE THE PT LATER EXPIRED. THE (B)(6) ALSO STATED THAT THE PT HAD MULTIPLE MEDICAL ISSUES INCLUDING RESPIRATORY PROBLEMS. THE (B)(4) FURTHER REPORTED THAT THE ELECTRODES APPEARED TO BE ADHERED TO THE PT APPROPRIATELY. THE CUSTOMER FURTHER REPORTED THAT THE DEFIBRILLATOR WAS INSPECTED BY PHYSIO-CONTROL WAS ADVISED THAT THE DEVICE WAS IN COMPLIANCE AND WAS WORKING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1310P MEDITRACE 2/PK 20/CA DEFIBRILLATION ELECTRODE MLN COVIDIEN 31319281 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other