BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 4372429 · Received December 30, 2014

    Report

    Report Number
    3015876-2014-01587
    Event Type
    Injury
    Date Received
    December 30, 2014
    Date of Event
    December 4, 2014
    Report Date
    December 4, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COPY OF THE CODE SUMMARY PRINTOUT WAS SENT TO PHYSIO-CONTROL FOR A CLINICAL ANALYSIS. A REVIEW OF THE REPORTED EVENT WAS CONDUCTED BY A CLINICAL SPECIALIST WHO CONCLUDED THAT THE CAUSE OF THE REPORTED ISSUE WAS USE ERROR. IT WAS OBSERVED IN THE CODE SUMMARY PRINTOUT THAT THE DEVICE USER FAILED TO TURN ON THE DEFIBRILLATOR'S SYNC FUNCTION PRIOR TO ADMINISTERING THE DEFIBRILLATOR SHOCK TO THE PATIENT AND, AS A RESULT, SHOCKED THE PATIENT ON THE T WAVE WHICH CAUSED THE PATIENT'S ECG RHYTHM TO CONVERT TO VENTRICULAR FIBRILLATION. THERE WAS NO FAILURE OF THE DEVICE. PHYSIO-CONTROL CONTACTED THE CUSTOMER TO ADVISE THEM OF THE INVESTIGATION RESULTS. THE CUSTOMER ADVISED PHYSIO THAT THEY TOO HAD BELIEVED THAT THE REPORTED ISSUE WAS THE RESULT OF USE ERROR, BUT WANTED A SECOND OPINION. PHYSIO OFFERED TO PROVIDE ADDITIONAL PRODUCT TRAINING BUT THE CUSTOMER DECLINED, ADVISING THAT ADDITIONAL TRAINING HAD ALREADY BEEN COMPLETED BY THE HOSPITAL STAFF. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER, A BIOMEDICAL ENGINEER, CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A RECENT PATIENT EVENT, THAT THEY BELIEVED THAT THE DEVICE PROVIDED A SYNCHRONIZED CARDIOVERSION DEFIBRILLATOR SHOCK ON THE PATIENT'S T WAVE INSTEAD OF THE R WAVE. AS A RESULT OF THE SHOCK, THE PATIENT'S HEART RHYTHM CONVERTED TO VENTRICULAR FIBRILLATION, A LIFE THREATENING CONDITION, WHICH REQUIRED MEDICAL INTERVENTION TO CORRECT. MEDICAL PERSONNEL THEN PROVIDED ONE (1) ADDITIONAL ASYNCHRONOUS SHOCK OF 200 JOULES TO THE PATIENT, 13 SECONDS AFTER THE INITIAL SHOCK, IN ORDER TO CORRECT THE PATIENT'S HEART RHYTHM. THE PATIENT, A MALE (AGE UNKNOWN), SURVIVED THE EVENT. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857116 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R