BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3193204 · Received June 27, 2013

    Report

    Report Number
    3015876-2013-00556
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE INTERFACE PCB ASSEMBLY AND THE FLEX CABLE ASSEMBLY WHICH CONNECTS THE SYSTEM AND INTERFACE PCB ASSEMBLIES. PROPER DEVICE OPERATION WAS THEN OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WOULD SHUT DOWN ON ITS OWN AND INTERMITTENTLY WOULDN'T POWER BACK ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292305 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1