BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3213422 · Received July 9, 2013

    Report

    Report Number
    3015876-2013-00592
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE AND OBSERVED THAT THE ANALOG PCB ASSEMBLY CAUSED THE DEVICE NOT TO POWER ON. PHYSIO-CONTROL DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO LEGS 1 AND 4 OF THE INDUCTOR, DESIGNATOR L1 ON THE ANALOG PCB ASSEMBLY, BEING SHORTED TO 14 K OHMS. THIS CAUSED THE DEVICE NOT TO POWER ANYMORE.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. A SERVICE INDICATOR ICON AND LOW BATTERY ICON WERE SHOWN IN THE DEVICE'S READINESS DISPLAY. THE DEVICE WOULD NOT POWER ON ANYMORE WITH ANY BATTERY. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER UNDER WARRANTY. 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.

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDWATCH REPORT INDICATES: (B)(4). THE INITIAL MEDWATCH REPORT SHOULD INDICATE: (B)(4). THE INITIAL MEDWATCH REPORT INDICATES: (B)(6). THE INITIAL MEDWATCH REPORT SHOULD INDICATE: (B)(6). THE INITIAL MEDWATCH REPORT INDICATES: (B)(6). THE INITIAL MEDWATCH REPORT SHOULD INDICATE: ASKU.

    Description of Event or Problem · 1

    IT WAS REPORTED TO A PHYSIO-CONTROL SERVICE REPRESENTATIVE THAT THE CUSTOMER'S DEVICE WOULD NOT POWER ON AND THAT A BEEP COULD BE HEARD FROM THE DEVICE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313619 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1