BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1698332 · Received May 20, 2010

    Report

    Report Number
    3015876-2010-00644
    Event Type
    Injury
    Date Received
    May 20, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 19, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THE FACILITY BIOMED EVALUATED THE DEVICE AND FOUND NO DEVICE FAILURE. PHYSIO-CONTROL ALSO EVALUATED THE DEVICE AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. A CLINICAL REVIEW OF THE EVENT RECORD DETERMINED THAT USE ERROR CAUSED THE REPORTED EVENT. THE PT HAD AN ATRIAL ARRHYTHMIA AND RECEIVED THREE SYNCHRONIZED SHOCKS BUT THE SYNCHRONIZATION FUNCTION WAS NOT TURNED ON PRIOR TO THE FOURTH SHOCK AND THE PT RECEIVED AN UNSYNCHRONIZED SHOCK AND CONVERTED TO VF. FOLLOWING DELIVERY OF A SYNCHRONIZED SHOCK, THE DEVICE WAS CONFIGURED TO DEACTIVATE THE SYNCHRONIZED SHOCK FUNCTION HENCE THE USER HAD TO TURN ON THE SYNCHRONIZED CARDIOVERSION IF THE TREATMENT WAS DESIRED. PHYSIO-CONTROL PROVIDED THE CUSTOMER ADD'L REFRESHER IN-SERVICE DEVICE TRAINING.

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDWATCH REPORT INDICATES: DATE OF EVENT -(B)(6) 2010. THE INITIAL MEDWATCH REPORT SHOULD HAVE INDICATED: DATE OF EVENT - (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SYNCHRONIZED CARDIOVERSION FUNCTION DID NOT OPERATE APPROPRIATELY DURING USE AND THE PT WAS SHOCKED IMPROPERLY. THE PT WAS BEING MONITORED USING THE ECG CABLE AND THE DEFIBRILLATOR ELECTRODES WERE CONNECTED TO THE PATIENT TO PROVIDE SYNCHRONIZED DEFIBRILLATION. IT WAS REPORTED THAT THE PATIENT WAS CARDIOVERTED SUCCESSFULLY THREE TIMES AND ON THE FOURTH SHOCK, THE PATIENT RECEIVED UNSYNCHRONIZED SHOCK AND WENT INTO VENTRICULAR FIBRILLATION (VF). THEREAFTER, THE USERS DELIVERED FIVE UNSYNCHRONIZED SHOCKS TO THE PATIENT AND CONVERTED HIM/HER TO A NORMAL SINUS RHYTHM. THE PT WAS REPORTED TO BE "OK" FOLLOWING THE EVENT. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR PATIENT PROVIDED. A CLINICAL REVIEW OF THE REPORTED INCIDENT DETERMINED THAT THE DEVICE USE CAUSED THE PATIENT TO BE IN A LIFE-THREATENING CONDITION SINCE THE PATIENT WAS IN A VIABLE STATE WITH ORGANIZED ECG RHYTHM AND THE FOURTH DEFIBRILLATION SHOCK PLACED THE PATIENT IN VF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R