BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 5345934 · Received January 5, 2016

    Report

    Report Number
    3015876-2016-00017
    Event Type
    Malfunction
    Date Received
    January 5, 2016
    Date of Event
    December 15, 2015
    Report Date
    January 5, 2016
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K130454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL RECOMMENDED THAT THE CUSTOMER, A BIOMEDICAL ENGINEER, REPLACE THE HARD PADDLES ASSEMBLY AND THAT PROPER DEVICE OPERATION THROUGH FUNCTIONAL TESTING BE COMPLETED PRIOR TO PLACING THE DEVICE BACK INTO SERVICE FOR USE. THE HARD PADDLES ASSEMBLY (PART NUMBER 3200936-030, LOT CODE 29200) WAS DISPOSED OF BY THE CUSTOMER; THEREFORE IT WAS NOT RETURNED TO PHYSIO-CONTROL FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER, A BIOMEDICAL ENGINEER, CONTACTED PHYSIO-CONTROL TO REPORT THAT WHILE PERFORMING A PREVENTATIVE MAINTENANCE (PM) INSPECTION ON THEIR DEVICE THAT THE ADULT PADDLE PLATE SEPARATED FROM PLASTIC HOUSING OF THE HARD PADDLES ASSEMBLY WHEN THEY WERE REMOVED FROM THE DEVICE'S PADDLE WELLS. AS A RESULT, DEFIBRILLATION WITH THE HARD PADDLES WAS NOT POSSIBLE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5495 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1