BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3230245 · Received July 16, 2013

    Report

    Report Number
    3015876-2013-00625
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER, A BIOMED, WAS UNABLE TO VERIFY OR DUPLICATE THE REPORTED FAILURE WHEN HE TESTED THE UNIT IMMEDIATELY AFTER THE PATIENT EVENT. AFTER MULTIPLE ATTEMPTS, PHYSIO-CONTROL HAS BEEN UNABLE TO CONTACT THE CUSTOMER REGARDING THE REPORTED ISSUE. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PATIENT EVENT THE DEVICE FAILED TO DELIVER A DEFIBRILLATION SHOCK. NO FURTHER INFORMATION ON THE PATIENT OR THE EVENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328626 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1