BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 8621820 · Received May 17, 2019

    Report

    Report Number
    0003015876-2019-00876
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 22, 2019
    Report Date
    February 4, 2020
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6: PHYSIO-CONTROL REPLACED THE SYSTEM PCB ASSEMBLY, AND PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 0

    PHYSIO-CONTROL FAILURE ANALYSIS CENTER FURTHER EVALUATED THE SYSTEM PCB ASSEMBLY AND OBSERVED THAT THE SINGLE BOARD COMPUTER (SBC) ON THE SYSTEM PCB ASSEMBLY WAS NOT FUNCTIONING CORRECTLY WHICH RESULTED IN THE DEVICE TO NOT COMPLETE ITS BOOT UP CYCLE.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE ITS INITIAL BOOT-UP CYCLE IN ORDER TO POWER ON. IN THIS STATE, DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF IT WAS NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE ITS INITIAL BOOT-UP CYCLE IN ORDER TO POWER ON. IN THIS STATE, DEFIBRILLATION THERAPY WOULD 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 PERFORMED AN INITIAL EVALUATION OF THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED ISSUE 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

    A CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE ITS INITIAL BOOT-UP CYCLE IN ORDER TO POWER ON. IN THIS STATE, DEFIBRILLATION THERAPY WOULD 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
    414202 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 15

    Patients

    Seq Age Sex Outcome Treatment
    1