BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADENCE PHYSIO QC ADULT RTS

    MDR report key: 3090317 · Received April 18, 2013

    Report

    Report Number
    1219103-2013-00018
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    April 7, 2013
    Report Date
    April 12, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 04/18/2013. 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 STATES A PT CAME INTO THE EMERGENCY ROOM AT (B)(6) IN CARDIAC ARREST. THEY APPLIED DEFIB ELECTRODES ON A PT AND THEY SUCCESSFULLY DELIVERED THE SHOCK, THEN ONE OF THE LEAD WIRES MELTED CAUSING THE WIRE TO BREAK. THE CUSTOMER FURTHER STATED THAT THE PT WAS NOT INJURED FROM THIS INCIDENT AND THE DEFIBS WERE NOT REPLACED BECAUSE THE PT DID NOT NEED THEM. THE CUSTOMER FURTHER STATED THAT 18 HOURS LATER THE PT EXPIRED OF OTHER COMPLICATIONS NOT RELATED TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167739 CADENCE PHYSIO QC ADULT RTS DEFIBRILLATION ELECTRODES MLN COVIDIEN 22550R UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK