BEUDAMED
    FDA Adverse Event Death Summary report: N

    OB CO#1310451,PKG,350P,PP01,EN,350-BAS-US-10

    MDR report key: 9792275 · Received March 5, 2020

    Report

    Report Number
    3004123209-2020-00052
    Event Type
    Death
    Date Received
    March 5, 2020
    Date of Event
    January 30, 2020
    Report Date
    May 19, 2020
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM350P
    PMA / PMN Number
    P160008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 350P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 350P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 29TH NOVEMBER 2016. THE USER POWERED ON THE DEVICE AND WAS ISSUED WITH THE ADVISORY SPEECH PROMPTS. AS PER THE CLINICAL STATEMENT, THE PATIENT PRESENTED VENTRICULAR FIBRILLATION (VF) AND THE DEVICE DELIVERED A SHOCK AT 00:00:20. WHEN THE CPR CYCLE WAS COMPLETE, THE VF HAD DETERIORATED TO FINE VF, BORDERING THE THRESHOLD FOR SHOCKABLE RHYTHMS SET BY THE DEVICE. AS A RESULT, THE DEVICE ALTERNATED BETWEEN ¿SHOCK ADVISED¿ AND ¿NO SHOCK ADVISED¿. FOLLOWING THE SECOND CPR CYCLE, THE DEVICE CONTINUED TO FLUCTUATE ON THE THRESHOLD FOR SHOCKABLE RHYTHMS. THE USER WAS TWICE PROMPTED TO PRESS THE SHOCK BUTTON, BUT THE BUTTON WAS NOT PRESSED BEFORE THE DECISION REVERSED, THEREFORE A FURTHER SHOCK WAS NOT DELIVERED. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT THE EVENT. DURING THE INVESTIGATION, THE RETURNED SAM 350P DELIVERED THE SHOCK THERAPY SEQUENCE WITHOUT FAULT USING THE RETURNED PAD-PAK, AND THE SPECIFIED AUDIO PROMPTS WERE ISSUED CLEARLY THROUGHOUT. NO FAULT WAS IDENTIFIED ON THE DEVICE THAT WOULD INHIBIT THE DETECTION OF A SHOCKABLE RHYTHM. FURTHERMORE, THE DEVICE DID DELIVER ONE SHOCK DURING THE REPORTED EVENT AND HAD ALSO DELIVERED SHOCK THERAPY 14 MONTHS PRIOR TO THE EVENT, ON THE 14TH OCTOBER 2018. THIS DEVICE SHALL BY RETAINED BY HEARTSINE AS PER COMPLAINT HANDLING PROCEDURE H001-003-080.

    Description of Event or Problem · 0

    CUSTOMER STATED PATIENT WAS IN CARDIAC ARREST, CUSTOMER PERFORMED CPR THEN DEPLOYED AED, PLACED PADS ON PATIENTS CHEST AND ANALYZED FOR SHOCK (UNIT STATED SHOCK NOT ADVISED) CUSTOMER HAD TO WAIT FOR FIRE DEPARTMENT TO ARRIVE WITH AED, CUSTOMER ALSO STATED PATIENT DID EXPIRE. SN: (B)(6). SYMPTOM DISPLAYED: DEFIBRILLATION ANALYSIS - DOES NOT DETECT SHOCKABLE RHYTHM. PATIENT EXPIRED.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2015058. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED PATIENT WAS IN CARDIAC ARREST, CUSTOMER PERFORMED CPR THEN DEPLOYED AED, PLACED PADS ON PATIENT'S CHEST AND ANALYZED FOR SHOCK (UNIT STATED SHOCK NOT ADVISED) CUSTOMER HAD TO WAIT FOR FIRE DEPARTMENT TO ARRIVE WITH AED, CUSTOMER ALSO STATED PATIENT DID EXPIRE. SN: (B)(4). SYMPTOM DISPLAYED: DEFIBRILLATION ANALYSIS - DOES NOT DETECT SHOCKABLE RHYTHM. PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255016 OB CO#1310451,PKG,350P,PP01,EN,350-BAS-US-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM 350P M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR