BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 4221613 · Received November 3, 2014

    Report

    Report Number
    3015876-2014-01302
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE CUSTOMER¿S DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL REPLACED THE POWER PCB ASSEMBLY. THEREAFTER PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND 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 WOULD NOT POWER ON DURING A PATIENT EVENT. ANOTHER DEVICE THAT WAS AVAILABLE AT THE SCENE OF THE INCIDENT WAS USED TO PROVIDE TREATMENT. THIS ISSUE IS PATIENT RELATED; HOWEVER, THERE WAS NO ADVERSE PATIENT OUTCOME. NO FURTHER DETAILS ABOUT THE PATIENT EVENT OR THE PATIENT WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702257 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1