BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3143405 · Received June 3, 2013

    Report

    Report Number
    3015876-2013-00466
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED INTERMITTENT PROBLEM. PHYSIO RE-SEATED ALL OF THE CONNECTIONS TO THE BATTERY PINS AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS REPAIRED AND THEN RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE INTERMITTENTLY FAILS TO POWER ON OR IT SPORADICALLY LOSES POWER WHEN BATTERY ONE IS INSTALLED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244747 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1