BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3903298 · Received June 30, 2014

    Report

    Report Number
    3015876-2014-00744
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL PROVIDED THE BIOMEDICAL ENGINEER WITH TECHNICAL ASSISTANCE AND THE PART NUMBER FOR REPLACEMENT THERAPY CONNECTOR AND QUIK COMBO THERAPY CABLE ASSEMBLIES. IT WAS LATER CONFIRMED BY THE BIOMED THAT THEY WILL BE REPLACING THE THERAPY CONNECTOR AND QUIK COMBO THERAPY CABLE ASSEMBLIES ON THE DEVICE. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WILL BE PLACED BACK INTO SERVICE FOR USE. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER, A BIOMEDICAL ENGINEER, CONTACTED PHYSIO-CONTROL TO REPORT THAT A PIN FROM A QUIK-COMBO THERAPY CABLE HAD BROKEN OFF AND BECOME LODGED IN THEIR DEVICE'S THERAPY CONNECTOR ASSEMBLY. THIS ISSUE COULD PREVENT DEFIBRILLATION THERAPY FROM BEING DELIVERED, IF NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381101 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1