BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 8385360 · Received March 4, 2019

    Report

    Report Number
    3004123209-2019-00094
    Event Type
    Death
    Date Received
    March 4, 2019
    Date of Event
    February 16, 2019
    Report Date
    July 24, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 300P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 300P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE (B)(6) 2011. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT THE REPORTED EVENT. DURING THE REPORTED PATIENT-INVOLVED EVENT (B)(6) 2019, THE DEVICE WAS POWERED ON AND THERE WAS INITIALLY AN ARTEFACT IN THE ICG TRACE THAT CORRESPONDED TO AN ARTEFACT ON THE ECG TRACE, THEREFORE NO SHOCK WAS ADVISED. THE PATIENT RHYTHM WAS ASSESSED ON FOUR FURTHER OCCASIONS, WITH NO SHOCK ADVISED. THE DEVICE MEMORY BECAME FULL DURING THE THIRD CPR CYCLE AND THEREFORE NO FURTHER CLINICAL DATA COULD BE OBTAINED BEYOND THIS POINT. THE PATIENT WAS PRESENTING A NON-SHOCKABLE RHYTHM PRIOR TO THE MEMORY BECOMING FULL AND THEREFORE ADVISED NO SHOCK. FURTHER INFORMATION FROM THE DEVICE MEMORY REVEALED THE DEVICE HAD BEEN PREVIOUSLY USED IN MULTIPLE PATIENT INVOLVED EVENTS THROUGHOUT ITS TIME IN SERVICE AND HAD ANALYSED MULTIPLE PATIENT RHYTHMS, CORRECTLY RECORDING APPROXIMATELY 85 MINUTES OF CLINICAL DATA PRIOR TO THE REPORTED EVENT. AS THE DEVICE HAS CAPACITY FOR ONLY 90 MINUTES OF DATA, THIS HAD RESULTED IN THE DEVICE MEMORY BECOMING FULL DURING THE REPORTED EVENT, THEREFORE THE DEVICE BEGAN TO ISSUE ¿MEMORY FULL¿ PROMPTS. AS PER THE LABELLING REVIEW, THIS ISSUE WOULD NOT HAVE IMPACTED THE DEVICE¿S ABILITY TO ANALYSE OR PERFORM SHOCK THERAPY. DURING INVESTIGATION, THE DEVICE CORRECTLY ANALYSED MULTIPLE TIMES AND DELIVERED THE FULL SHOCK THERAPY SEQUENCE WITHOUT FAULT. THE DEVICE WAS CONFIRMED TO RECORD ECG DATA ACCURATELY WITHOUT NOISE OR OTHER ABNORMALITIES. THIS DEVICE SHALL BY RETAINED BY HEARTSINE AS PER COMPLAINT HANDLING PROCEDURE (B)(4).

    Description of Event or Problem · 0

    300P DEVICE WAS USED DURING AN ALLEGED SCA ON (B)(6) 2019. IT WAS REPORTED THAT THE DEVICE DID NOT PROVIDE ANY ANALYSIS WHEN CONNECTED TO THE PATIENT. A SECOND DEVICE WAS USED AT THE SCENE AND IT REPORTEDLY HAD THE SAME ISSUE. CPR WAS PERFORMED ON THE PATIENT. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT DID NOT SURVIVE.

    Description of Event or Problem · 0

    300P DEVICE WAS USED DURING AN ALLEGED SCA ON (B)(6) 2019. IT WAS REPORTED THAT THE DEVICE DID NOT PROVIDE ANY ANALYSIS WHEN CONNECTED TO THE PATIENT. A SECOND DEVICE WAS USED AT THE SCENE AND IT REPORTEDLY HAD THE SAME ISSUE. CPR WAS PERFORMED ON THE PATIENT. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178962 AUTOMATED EXTERNAL DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Death