BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    MDR report key: 8824250 · Received July 24, 2019

    Report

    Report Number
    0003015876-2019-01257
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    June 25, 2019
    Report Date
    September 5, 2019
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    PMA / PMN Number
    K130454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND WAS UNABLE TO DUPLICATE OR VERIFY THE REPORTED ISSUE. AFTER PERFORMING OTHER UNRELATED REPAIRS, PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE CUSTOMER FOR USE. THE ROOT CAUSE OF THE REPORTED ISSUE WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE PROVIDED INSUFFICIENT ENERGY WHEN DELIVERING DEFIBRILLATION THERAPY INTO A SIMULATOR. AS A RESULT, ADEQUATE DEFIBRILLATION 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 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 PROVIDED INSUFFICIENT ENERGY WHEN DELIVERING DEFIBRILLATION THERAPY INTO A SIMULATOR. AS A RESULT, ADEQUATE DEFIBRILLATION 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
    616146 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 20E

    Patients

    Seq Age Sex Outcome Treatment
    1