BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    MDR report key: 2851170 · Received November 29, 2012

    Report

    Report Number
    3015876-2012-00861
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K073089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE THERAPY PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED THERAPY PCB ASSEMBLY AT THE FAILURE ANALYSIS CENTER AND DETERMINED THE CAUSE FOR THE FAILURE TO BE TWO BURNT RESISTORS, DESIGNATORS R149 AND R150. DAMAGE TO THE RESISTORS COULD HAVE BEEN CAUSED BY CUSTOMER'S UTILIZATION OF DAMAGED THERAPY DELIEVERY ACCISSORIES. HOWEVER, FURTHER CONCLUSIVE CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED TO RECOGNIZE A CONNECTION TO A THERAPY CABLE WHEN TRYING TO DELIVER THERAPY TO A PATIENT. THE EVENT REPORTER BELIEVED A BACK-UP DEVICE WAS AVAILABLE AND USED ON THE PATIENT; HOWEVER THIS COULD NOT BE CONFIRMED. THERE WAS NO FURTHER INFORMATION ON THE PATIENT OR EVENT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED TO RECOGNIZE A CONNECTION TO A THERAPY CABLE WHEN TRYING TO DELIVER THERAPY TO A (B)(6) FEMALE PATIENT. THE PATIENT WAS INITIALLY IN RESPIRATORY ARREST. ANOTHER LIFEPAK(R) 20E DEVICE WAS AVAILABLE AND WAS USED TO DELIVER ONE SHOCK TO THE PATIENT. THE EXACT DELAY BETWEEN USE OF THE FIRST AND SECOND DEVICE WAS NOT KNOWN; HOWEVER IT WAS NOTED AS BEING A SHORT PERIOD OF TIME. A DIFFERENT THERAPY CABLE WAS USED WITH THE SECOND DEVICE. THE PATIENT WAS RESUSCITATED AND TAKEN TO THE SCU, INTUBATED AND PLACED ON A VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 20E

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR