BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3854221 · Received June 6, 2014

    Report

    Report Number
    3015876-2014-00630
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    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). PHYSIO-CONTROL HAS MADE SEVERAL ATTEMPTS TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT AND THE REPORTED FAILURE BUT HAVE BEEN UNSUCCESSFUL IN DOING SO. THE CUSTOMER HAS NOT BEEN AVAILABLE. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER NOTIFIED PHYSIO-CONTROL THAT THEY HAVE EVALUATED THE DEVICE AND THE INTERNAL DEFIBRILLATION PADDLES ASSEMBLY AND OBSERVED PITTING ON THE PADDLE PLATES. THE CUSTOMER HAS SINCE REPLACED THE INTERNAL DEFIBRILLATION PADDLES ASSEMBLY AND HAS RETURNED THE DEVICE TO SERVICE FOR USE. THE DEVICE WILL NOT BE RETURNED TO PHYSIO-CONTROL FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER FOLLOWED UP WITH THE CUSTOMER AND THE CUSTOMER CONFIRMED THAT THE REPORTED ABNORMAL ENERGY DELIVERY MESSAGE WAS A RESULT OF AN OPEN AIR DISCHARGE OF THE PADDLES ASSEMBLY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS GIVING AN "ABNORMAL ENERGY DELIVERY" MESSAGE WHEN ATTEMPTING TO DELIVER DEFIBRILLATION ENERGY. THERE WAS PATIENT USE ASSOCIATED BUT NO DETAILS OF THE PATIENT EVENT HAVE BEEN REPORTED. THE CUSTOMER DID REPORT THAT WHEN THE REPORTED DEVICE ISSUE OCCURRED, THEY HAD A BACK UP DEVICE AND INTERNAL DEFIBRILLATION PADDLES AVAILABLE FOR USE. THERE WERE NO KNOWN ADVERSE EFFECTS CAUSED TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332793 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1