BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3083410 · Received April 29, 2013

    Report

    Report Number
    3015876-2013-00340
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    November 18, 2019
    Report Date
    November 22, 2019
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Removal / Correction Number
    3015876-11/18/2019- 001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER AN ADDITIONAL INVESTIGATION PERFORMED AND REPORTED ON MEDWATCH #3015876-2017-000035, PHYSIO-CONTROL DETERMINED THAT THE LIKELY CAUSE OF THIS REPORTED ISSUE WAS DUE TO THE SHOCK BUTTON ON THE MAIN KEYPAD ASSEMBLY MEASURING HIGHER THAN NORMAL RESISTANCE. THE HIGH RESISTANCE CAUSED THE DEVICE TO DUMP THE DEFIBRILLATION CHARGE WHEN THE SHOCK BUTTON WAS PRESSED. PHYSIO-CONTROL PERFORMED A REPLACEMENT OF THE MAIN KEYPAD ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING.

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED FAILURE. HOWEVER, PHYSIO OBSERVED AN EVENT CODE LOGGED IN THE MEMORY THAT COULD HAVE RELATED TO THE REPORTED INSTANCE. PHYSIO OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND RETURNED THE DEVICE TO THE CUSTOMER FOR USE. A CONCLUSIVE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL MDR IS REQUIRED TO DOCUMENT THAT FIELD ACTION NUMBER 3015876-11/18/2019-001C IS RELEVANT TO THIS REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED TO DELIVER DEFIBRILLATION ENERGY, PRESSING THE SHOCK BUTTON DISARMED THE CHARGED ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Description of Event or Problem · 1

    SUPPLEMENTAL MDR IS REQUIRED TO DOCUMENT THAT FIELD ACTION NUMBER 3015876-11/18/2019-001C IS RELEVANT TO THIS REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185600 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 15

    Patients

    Seq Age Sex Outcome Treatment
    1