BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK® 15 DEFIBRILLATOR/MONITOR

    MDR report key: 8384975 · Received March 3, 2019

    Report

    Report Number
    0003015876-2019-00368
    Event Type
    Malfunction
    Date Received
    March 3, 2019
    Date of Event
    February 1, 2019
    Report Date
    March 3, 2019
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    UDI-DI
    00883873988039
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO OBSERVED THAT THE BATTERY KEP NUT WAS LOOSE INSIDE THE DEVICE. PHYSIO TIGHTENED THE BATTERY KEP NUT AND REPLACED THE DEVICE'S BATTERY PINS. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERS OFF WHEN IT IS HIT. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178162 LIFEPAK® 15 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 15 00883873988039

    Patients

    Seq Age Sex Outcome Treatment
    1