BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIK-COMBO(R) PACING/DEFIBRILLATION/ECG ELECTRODES

    MDR report key: 3133007 · Received May 29, 2013

    Report

    Report Number
    3015876-2013-00442
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MLN
    PMA / PMN Number
    K960329
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE RETURNED DEFIBRILLATION ELECTRODES AND VERIFIED THE REPORTED FAILURE. IT WAS OBSERVED THAT THE APEX QUIK-COMBO CONNECTOR PIN WAS NOT MOLDED STRAIGHT INTO THE PLASTIC WHICH LED TO THE FAILURE TO CONNECT THESE ELECTRODES TO THE DEVICE. THE CUSTOMER RECEIVED A REPLACEMENT SET OF DEFIBRILLATION ELECTRODES.

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHYSIO-CONTROL THAT A SET OF THE CUSTOMER'S ADULT QUIK-COMBO DEFIBRILLATION ELECTRODES WOULD NOT PLUG IN TO THE DEVICE CONNECTOR DURING A PATIENT EVENT DUE TO A BENT PIN IN THE PLUG OF THE ELECTRODES. A SECOND SET OF ELECTRODES WERE RETRIEVED AND USED SUCCESSFULLY ON THE PATIENT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT, OR THE EVENT, WERE MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235809 QUIK-COMBO(R) PACING/DEFIBRILLATION/ECG ELECTRODES ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION MLN PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1