BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 9099827 · Received September 20, 2019

    Report

    Report Number
    0003015876-2019-01576
    Event Type
    Death
    Date Received
    September 20, 2019
    Date of Event
    September 8, 2019
    Report Date
    April 2, 2020
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    PMA / PMN Number
    K122600
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E1 INITIAL REPORTER POSTAL CODE OF THE INITIAL MEDWATCH REPORT WAS BLANK. SECTION E1 INITIAL REPORTER POSTAL CODE OF THE INITIAL MEDWATCH REPORT SHOULD INDICATE: (B)(6).

    Additional Manufacturer Narrative · 0

    PHYSIO-CONTROL OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE CUSTOMER FOR USE. THE PRESENCE OF ECG ARTIFACT AND LOW VT RATE LED TO THE "NO SHOCK ADVISED" DECISION MADE BY THE DEVICE. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD INITIALLY NOT RECOGNIZED A SHOCKABLE ECG RHYHTM DURING A PATIENT EVENT. THE DEVICE RETURNED "NO SHOCK ADVISED" DETERMINATION FOR ITS FIRST ANALYSIS, HOWEVER THE ATTENDING PARAMEDIC BELIEVED THE RHYTHM TO BE VENTRICULAR FIBRILLATION. A LIFEPAK 15 MONITOR/DEFIBRILLATOR (CATALOG NUMBER 99577-001388/ SERIAL NUMBER (B)(6)) WAS SUBSEQUENTLY CONNECTED TO THE PATIENT AND MADE A SIMILAR "NO SHOCK ADVISED" DETERMINATION FOR ITS FIRST THREE ANALYSES. FOR THE FOURTH ANALYSES THE LIFEPAK 15 DID PROVIDE A "SHOCK ADVISED" DETERMINATION AND A TOTAL OF THREE SHOCKS WERE DELIVERED TO THE PATIENT. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY DEPARTMENT (ED) AND THERE WAS NO RETURN OF SPONTANEOUS CIRCULATION. THE RESUSCITATION WAS EVENTUALLY STOPPED AND THE PATIENT WAS DECLARED DECEASED IN THE EMERGENCY DEPARTMENT.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD INITIALLY NOT RECOGNIZED A SHOCKABLE ECG RHYHTM DURING A PATIENT EVENT. THE DEVICE RETURNED "NO SHOCK ADVISED" DETERMINATION FOR ITS FIRST ANALYSIS, HOWEVER THE ATTENDING PARAMEDIC BELIEVED THE RHYTHM TO BE VENTRICULAR FIBRILLATION. A LIFEPAK 15 MONITOR/DEFIBRILLATOR (CATALOG NUMBER 99577-001388/ SERIAL NUMBER (B)(4)) WAS SUBSEQUENTLY CONNECTED TO THE PATIENT AND MADE A SIMILAR "NO SHOCK ADVISED" DETERMINATION FOR ITS FIRST THREE ANALYSES. FOR THE FOURTH ANALYSES THE LIFEPAK 15 DID PROVIDE A "SHOCK ADVISED" DETERMINATION AND A TOTAL OF THREE SHOCKS WERE DELIVERED TO THE PATIENT. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY DEPARTMENT (ED) AND THERE WAS NO RETURN OF SPONTANEOUS CIRCULATION. THE RESUSCITATION WAS EVENTUALLY STOPPED AND THE PATIENT WAS DECLARED DECEASED IN THE ED.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL REVIEWED THE PROVIDED ELECTRONIC PATIENT RECORD OF THE REPORTED EVENT, AND IT WAS OBSERVED THAT THE PRESENCE OF ECG ARTIFACT AND LOW VT RATE LED TO THE "NO SHOCK ADVISED" DECISION MADE BY THE DEVICE. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION, AS THE SHOCK ADVISORY ALGORITHM IS A DIAGNOSTIC TEST AND DIAGNOSTIC TESTS ALWAYS HAVE A LEVEL OF ACCURACY THAT IS LESS THAN 100%. THERE IS AN ACCEPTABLE LEVEL OF SENSITIVITY AND SPECIFICITY AS SET BY STANDARDS FOR AED PERFORMANCE . THE ESTABLISHED PERFORMANCE OF OUR ALGORITHM IS BASED ON TESTING WITH LARGE DATA SETS AND EXCEEDS THESE STANDARDS. PHYSIO-CONTROL PERFORMED AN INITIAL EVALUATION OF THE CUSTOMER'S DEVICE AND WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED ISSUE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD INITIALLY NOT RECOGNIZED A SHOCKABLE ECG RHYTHM DURING A PATIENT EVENT. THE DEVICE RETURNED "NO SHOCK ADVISED" DETERMINATION FOR ITS FIRST ANALYSIS, HOWEVER THE ATTENDING PARAMEDIC BELIEVED THE RHYTHM TO BE VENTRICULAR FIBRILLATION. A LIFEPAK 15 MONITOR/DEFIBRILLATOR (CATALOG NUMBER 99577-001388/ SERIAL NUMBER (B)(4)) WAS SUBSEQUENTLY CONNECTED TO THE PATIENT AND MADE A SIMILAR "NO SHOCK ADVISED" DETERMINATION FOR ITS FIRST THREE ANALYSES. FOR THE FOURTH ANALYSES THE LIFEPAK 15 DID PROVIDE A "SHOCK ADVISED" DETERMINATION AND A TOTAL OF THREE SHOCKS WERE DELIVERED TO THE PATIENT. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY DEPARTMENT (ED) AND THERE WAS NO RETURN OF SPONTANEOUS CIRCULATION. THE RESUSCITATION WAS EVENTUALLY STOPPED AND THE PATIENT WAS DECLARED DECEASED IN THE ED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890545 LIFEPAK(R) 1000 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death