BEUDAMED
    FDA Adverse Event Other Summary report: N

    1210H MEDITRACE 2/PK 20/CA

    MDR report key: 3368458 · Received September 19, 2013

    Report

    Report Number
    9681860-2013-00023
    Event Type
    Other
    Date Received
    September 19, 2013
    Date of Event
    September 4, 2013
    Report Date
    September 4, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH DEFIBRILLATION ELECTRODES. THE CUSTOMER REPORTS THAT WHILE USING THE DEFIB PADS ON A (B)(6) FEMALE IN V FIB V-TACH AT APPROXIMATELY 9:15AM ON (B)(6) 2013, THE PHILIPS HEART START MRX MACHINE SHOWED A MESSAGE THAT NO SHOCK WAS DELIVERED; HOWEVER, THE STAFF KNOWS A SHOCK WAS DELIVERED TO THE PATIENT. THE STAFF KNEW THAT THE SHOCK WAS DELIVERED BECAUSE THEY COULD SEE THE BREAK ON THE STRIP AND THE PATIENT'S BODY JUMPED. THE HOSPITAL STAFF APPLIED A SECOND SET OF THE SAME DEFIB PADS TO THE PATIENT AND RECEIVED THE SAME MESSAGE. THE CUSTOMER CONFIRMED THAT A SHOCK WAS DELIVERED WITH BOTH SETS OF PADS. TWO DIFFERENT PHILIPS HEART START MRX MACHINES WERE USED ON THIS PATIENT, BOTH GIVING THE SAME MESSAGE. THE PATIENT EXPIRED 12 MINUTES AFTER APPLYING THE SECOND SET OF PADS. THE COVIDIEN 1210H MEDITRACE ELECTRODES ARE CURRENTLY STILL ON THE PATIENT'S BODY. THE HOSPITAL STAFF STATED THAT THE PATIENT HAD A NUMBER OF PRE-EXISTING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472917 1210H MEDITRACE 2/PK 20/CA DEFIBRILLATION ELECTRODES MLN COVIDIEN 31177721 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other