BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 6093290 · Received November 10, 2016

    Report

    Report Number
    3015876-2016-01351
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    September 29, 2016
    Report Date
    November 10, 2016
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO REPLACED THE MAIN KEYPAD ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED KEYPAD ASSEMBLY AND OBSERVED THE POWER BUTTON TO BE WORN ON THE LEFT SIDE, BUT DID NOT OBSERVED ANY LOSS OF POWER DURING ADDITIONAL TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED A NON CRITICAL ISSUE RELATED TO INTERMITTENT KEY FUNCTIONALITY. UPON EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT THE DEVICE LOST POWER FOLLOWING A DEFIBRILLATION SHOCK AND WOULD NOT POWER BACK ON. THIS OBSERVATION WAS DURING TESTING AND THERE WAS NO REPORT OF ANY PATIENT USE ASSOCIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744572 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1