BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 8176311 · Received December 18, 2018

    Report

    Report Number
    0003015876-2018-02142
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    November 20, 2018
    Report Date
    December 18, 2018
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    UDI-DI
    00883873871683
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO DETERMINED THE CAUSE OF THE REPORTED ISSUE WAS DUE TO 3 OF THE 4 KEP NUTS THAT RETAIN THE BATTERY PINS HAD BECOME LOOSE. PHYSIO REPLACED THE REAR CASE OF THE DEVICE AND THE 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 POWERED OFF BY ITSELF DURING A PATIENT EVENT. THIS OCCURRED WHEN MONITORING THE PATIENT. THE CUSTOMER ADVISED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. PHYSIO-CONTROL HAS ATTEMPTED TO CONTACT THE CUSTOMER FOR FURTHER INFORMATION ON THE EVENT AND PATIENT, BUT HAS BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015558 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 15 00883873871683

    Patients

    Seq Age Sex Outcome Treatment
    1