BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 15 DEFIBRILLATOR/MONITOR

    MDR report key: 11341548 · Received February 18, 2021

    Report

    Report Number
    0003015876-2021-00433
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    February 12, 2021
    Report Date
    February 18, 2021
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    UDI-DI
    00883873871713
    PMA / PMN Number
    P160026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. PHYSIO TIGHTENED THE DEVICE'S WIRE HARNESS KEP NUTS TO RESOLVE THE REPORTED ISSUE. 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 SHUT DOWN. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241391 LIFEPAK 15 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 15 00883873871713

    Patients

    Seq Age Sex Outcome Treatment
    1