BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3881111 · Received June 18, 2014

    Report

    Report Number
    3015876-2014-00670
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY OR DUPLICATE THE REPORTED FAILURE. THE CUSTOMER STATED THAT THE DEFIBRILLATION ELECTRODES WHICH HAD REPORTEDLY FAILED TO RECOGNIZE THE PATIENT WERE DISPOSED OF FOLLOWING THE PATIENT EVENT. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT EVENT, THEIR DEVICE WAS UNABLE TO DETECT THE PATIENT WHEN THE DEFIBRILLATION THERAPY ELECTRODES WERE CONNECTED. THE CUSTOMER STATED THAT THE PATIENT (AGE IN HIS (B)(6)) WAS FOUND ON THE GROUND, UNRESPONSIVE. THE PATIENT'S DOWNTIME WAS UNKNOWN. THE INITIAL RESPONDER INITIATED CPR AS THE DEVICE WAS BEING RETRIEVED. AS ANOTHER RESPONDER CONTINUED CPR, THE CUSTOMER OPENED THE FIRST PACKAGE OF DEFIBRILLATION ELECTRODES AND APPLIED THEM TO THE PATIENT, BUT THE DEVICE DIDN¿T RECOGNIZE THE CONNECTION. THE PATIENT'S SKIN CONDITION DIDN¿T APPEAR OUT OF THE ORDINARY AND NOT NOTICEABLY HAIRY, SWEATY, OR DRY. NO SKIN PREP WAS DONE. AFTER DOING A QUICK CHECK OF CONNECTIONS, THE CUSTOMER GRABBED ANOTHER PACKAGE OF DEFIBRILLATION ELECTRODES, OPENED IT AND APPLIED THEM TO THE PATIENT WHICH APPEARED TO RECOGNIZE THE PATIENT NORMALLY. DURING THE EVENT, THE CUSTOMER ESTIMATED THAT MINIMAL CPR COMPRESSIONS WERE NEEDED BEFORE THE PATIENT STARTED TO RESPOND. NO SHOCKS WERE NEEDED OR PROVIDED. THE PATIENT DID NOT SUFFER ANY ADVERSE EFFECTS AS A RESULT OF THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358375 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1