BEUDAMED
    FDA Adverse Event Other Summary report: N

    1310P MEDITRACE 2/PK 20/CA

    MDR report key: 3031919 · Received March 25, 2013

    Report

    Report Number
    9681860-2013-00003
    Event Type
    Other
    Date Received
    March 25, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 26, 2013
    Manufacturer
    COVIDIEN
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 AFTER CLEANING AND DRYING THE SKIN, THE ELECTRODES WERE APPLIED TO A PT WHILE IN CARDIAC ARREST. THEY WERE BEING USED TO POTENTIALLY SHOCK THE PT. THE CUSTOMER NOTICED THAT THE PADS WERE BUNCHING UP ON THE PT AND REMOVED THEM. THEY THEN APPLIED A DIFFERENT SET OF PADS TO THE PT THAT WERE MADE BY A DIFFERENT MFR AND WITHIN 5 MINUTES WERE ADVISED TO SHOCK THE PT. THE PADS WERE BEING USED IN CONJUNCTION WITH A PHYSIO LIFEPAK MONITOR. THE CUSTOMER FURTHER REPORTS THAT THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122363 1310P MEDITRACE 2/PK 20/CA DEFIBRILLATION ELECTRODES DRX COVIDIEN 31319281 231103

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other