BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3073274 · Received April 23, 2013

    Report

    Report Number
    3015876-2013-00328
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL PROVIDED THE CUSTOMER TECHNICAL ASSISTANCE AND RECOMMENDED CHECKING THE BATTERY AGE OR MANUFACTURER INFORMATION. THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL FOR ANALYSIS/REPAIR. 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.

    Additional Manufacturer Narrative · 1

    CORRECTION/ADDITIONAL INFORMATIONPHYSIO-CONTROL PROVIDED THE REPORTER, A THIRD PARTY BIOMED, TECHNICAL ASSISTANCE AND RECOMMENDED CHECKING THE BATTERY AGE AND MANUFACTURER INFORMATION. ADDITIONAL FOLLOW UP WITH THE REPORTER FOUND THAT THE THIRD PARTY BIOMED EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE BIOMED TESTED THE DEVICE WITH BATTERIES THAT WERE PROVIDED BY THE CUSTOMER AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE.THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL FOR ANALYSIS. A CONCLUSIVE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SHUTS DOWN WHEN THE CHARGE BUTTON WAS PRESSED WHILE RUNNING ON BATTERY. THE DEVICE OPERATES PROPERLY WITH TWO FULLY CHARGED BATTERIES OR ON AC POWER. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174570 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1