BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 4090233 · Received September 15, 2014

    Report

    Report Number
    3015876-2014-01083
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K052057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY THE REPORTED FAILURE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED DEVICE FAILURE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDWATCH REPORT SHOULD HAVE INDICATED: DATE DEVICE WAS RETURNED TO MANUFACTURER - (B)(4) 2014.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT EVENT, THEIR DEVICE REPORTEDLY REPEATED "CONNECT ELECTRODES" WHEN THE DEFIBRILLATION ELECTRODES WERE CONNECTED TO THE PATIENT. THE CUSTOMER WAS UNABLE TO PROVIDE ANY ADDITIONAL DETAILS OF THE REPORTED EVENT. THERE WERE NO ADVERSE EFFECTS REPORTED TO HAVE BEEN CAUSED TO THE PATIENT AS A RESULT OF THE REPORTED DEVICE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568830 BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1