BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    MDR report key: 3213456 · Received July 9, 2013

    Report

    Report Number
    3015876-2013-00590
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K073089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE THIRD PARTY CONTRACT SERVICE PERSONNEL ADVISED PHYSIO-CONTROL THAT THE BATTERY WAS NORMALLY DEPLETED. AFTER CHARGING UP THE BATTERY ASSEMBLY, THE DEVICE FUNCTIONED NORMALLY. THE DEVICE HAS SINCE BEEN RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED ISSUE WAS LIKELY DUE TO USE ERROR. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NO LONGER POWER ON IN AC OR DC MODE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313647 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 20E

    Patients

    Seq Age Sex Outcome Treatment
    1