BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    MDR report key: 2468267 · Received February 24, 2012

    Report

    Report Number
    3015876-2012-00133
    Event Type
    Injury
    Date Received
    February 24, 2012
    Date of Event
    January 26, 2012
    Report Date
    January 27, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K073089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED FAILURE. PHYSIO OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. CLINICAL REVIEW OF THE EVENT DOWNLOAD DETERMINED THE CAUSE FOR ISSUE TO BE USE ERROR. THE DEVICE OPERATOR WAS ERRONEOUSLY ATTEMPTING TO TRANSFER THE CHARGED ENERGY BY PUSHING THE FRONT PANEL SHOCK BUTTON INSTEAD OF THE PADDLES SHOCK BUTTONS. THE FRONT PANEL SHOCK BUTTON IS DISABLED WHEN THE DEVICE IS UTILIZED WITH THE STANDARD PADDLES. IF THE FRONT PANEL SHOCK BUTTON IS ERRONEOUSLY PRESSED DURING USE OF THE STANDARD PADDLES, THE DEVICE PROVIDES AN AUDITORY ALERT TONE AND DISPLAYS A PROMPT ALONG WITH A GRAPHIC RENDITION OF THE PADDLES BUTTONS ON THE SCREEN.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL RECEIVED FURTHER INFORMATION FROM THE CUSTOMER THAT THEY HAVE DETERMINED THAT THE DEVICE USE DID NOT CONTRIBUTE TO THE OUTCOME OF THE PATIENT. FURTHER INFORMATION STATED THAT CPR WAS ADMINISTERED DURING THE TIME IN WHICH THE BACKUP DEVICE WAS BEING RETRIEVED AND ALSO THAT THE PATIENT WAS SUCCESSFULLY RESUSCITATED DURING THE REPORTED EVENT, BUT DID DIE LATER DUE TO PRE-EXISTING CO-MORBIDITY FACTORS. PHYSIO HAS CLASSIFIED THIS AS NEITHER AN ADVERSE EVENT OR A PRODUCT PROBLEM.

    Description of Event or Problem · 1

    DURING A CODE, IT WAS REPORTED THAT THE DEVICE WOULD NOT PROVIDE THE CHARGED DEFIBRILLATION ENERGY TO A PATIENT. THE NURSE THAT OPERATED THE DEVICE WAS ATTEMPTING TO PROVIDE A DEFIBRILLATION SHOCK WITH PADDLES. A BACK UP DEFIBRILLATOR WAS RETRIEVED AND SHOCKED THE PATIENT AFTER FIVE MINUTES. THE PATIENT RECEIVED CPR IN-BETWEEN DEVICES. THE PATIENT WAS RESUSCITATED AND WAS REPORTED TO BE ON A VENTILATOR AT CCU. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR THE PATIENT PROVIDED.

    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 Life Threatening| O