BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK® 20E DEFIBRILLATOR/MONITOR

    MDR report key: 9555805 · Received January 6, 2020

    Report

    Report Number
    0003015876-2020-00033
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    December 9, 2019
    Report Date
    March 26, 2020
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    UDI-DI
    00883873852798
    PMA / PMN Number
    K130454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND WAS ABLE TO DUPLICATE THE REPORTED ISSUE. PHYSIO REPLACED THE THERAPY PCB ASSEMBLY TO RESOLVE THE REPORTED ISSUE. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED THERAPY PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS DUE TO PART U35, THE OPTO-ISOLATOR. THE SOUTH EAST PORTION OF THE H-BRIDGE WAS NON-FUNCTIONAL THUS PROVIDING MONOPHASIC ENERGY, AND THE NEGATIVE PHASE OF THE ENERGY CURRENT.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON TESTING BY PHYSIO-CONTROL, THE DEVICE DELIVERED MONOPHASIC ENERGY INSTEAD OF BIPHASIC ENERGY, AND DELIVERED 185.7 J OF ENERGY INSTEAD OF 200 J.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE CUSTOMER¿S DEVICE AND DETERMINED THAT THE DEVICE REQUIRES REPLACEMENT OF THE SYSTEM PCB ASSEMBLY. 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 A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON TESTING BY PHYSIO-CONTROL, THE DEVICE DELIVERED MONOPHASIC ENERGY INSTEAD OF BIPHASIC ENERGY, AND DELIVERED 185.7 J OF ENERGY INSTEAD OF 200 J.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18025 LIFEPAK® 20E DEFIBRILLATOR/MONITOR AUTOMATIC EXTERNAL DEFIBRILLATOR (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 20E 00883873852798

    Patients

    Seq Age Sex Outcome Treatment
    1