BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK® 15 DEFIBRILLATOR/MONITOR

    MDR report key: 8667852 · Received June 4, 2019

    Report

    Report Number
    0003015876-2019-00963
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 13, 2019
    Report Date
    June 9, 2020
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    UDI-DI
    00883873979358
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PHYSIO-CONTROL EVALUATED THE REMOVED SYSTEM PCB ASSEMBLY AND FOUND THE ROOT CAUSE IS A SINGLE BOARD COMPUTER (SBC) CARD.

    Additional Manufacturer Narrative · 0

    PHYSIO-CONTROL DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS DUE TO THE SYSTEM PCB ASSEMBLY. AT THIS TIME, THIS DEVICE CANNOT BE REPAIRED DUE TO PART OBSOLESCENCE. THE CUSTOMER HAS RECEIVED A LOANER UNTIL A PERMANENT SOLUTION FOR THIS COMPLAINT IS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE SERVICE INDICATOR IS PRESENT ON THEIR DEVICE AND IT WILL NOT COMPLETE THE BOOT-UP PROCESS. AS A RESULT, DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE, IF IT WAS NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE SERVICE INDICATOR IS PRESENT ON THEIR DEVICE AND IT WILL NOT COMPLETE THE BOOT-UP PROCESS. AS A RESULT, DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE, IF IT WAS NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE SERVICE INDICATOR IS PRESENT ON THEIR DEVICE AND IT WILL NOT COMPLETE THE BOOT-UP PROCESS. AS A RESULT, DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE, IF IT WAS NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459813 LIFEPAK® 15 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 15 00883873979358

    Patients

    Seq Age Sex Outcome Treatment
    1