BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 4201681 · Received October 27, 2014

    Report

    Report Number
    3015876-2014-01266
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE BUT COULD NOT OBSERVE THE REPORTED ISSUE ANYMORE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. A LIGHTER CONTRAST WAS OBSERVED IN THE AREA ABOVE AND BELOW THE 'CONNECT ELECTRODE' SYMBOL ON THE LCD DISPLAY, BUT THIS WAS STILL WITHIN THE DEVICE MANUFACTURING SPECIFICATION. NO EVENT CODES HAD BEEN LOGGED INTO THE DEVICE MEMORY. THE DEVICE WOULD CHARGE AND SHOCK DELIVER DEFIBRILLATION ENERGY. A CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. 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 THE DISPLAY OF THEIR DEVICE WAS DISTORTED. THE DISPLAY SHOWED BLACK AND WHITE VERTICAL STRIPES WHEN THE DEVICE WAS POWERED ON, AND NO PROMPTS OR OTHER INFORMATION WAS VISIBLE. AS A RESULT, THE DEVICE USER MAY NOT BE ABLE TO SEE THE LABEL FOR THE ANALYZE BUTTON, WHICH THE DEVICE USER WOULD NEED TO PRESS IN ORDER TO DETERMINE THE NEED FOR DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682417 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1