BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6574703 · Received May 18, 2017

    Report

    Report Number
    3004123209-2017-00458
    Event Type
    Death
    Date Received
    May 18, 2017
    Date of Event
    April 10, 2017
    Report Date
    June 1, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    Z-0124-2013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD IS SUBMITTING THE REPORT ON TECHNOLOGIES LLC ( IMPORTER BEHALF OF HEARTSINE) H3 OTHER TEXT : NOT YET RETURNED TO MANUFACTURER

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF (B)(4). THE DEVICE HISTORY RECORDS FOR THE RETURNED SAM 300P DEVICE WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE DESPATCH OF THE SAM 300P FROM HEARTSINE TECHNOLOGIES, BELFAST ON (B)(6) 2007. ON RECEIPT OF THE DEVICE THE HISTORY AND MEMORY LOGS WERE DOWNLOADED.BETWEEN THE (B)(6) 2014 AND THE (B)(6) 2017 SEVERAL RECORD RANDOM MANUAL POWER UPS WERE RECORDED. ON ONE OCCASION THE DEVICE WAS ATTACHED TO A PATIENT WITH AN IN-RANGE IMPEDANCE BEING MEASURED AND A 150J SHOCK BEING SUCCESSFULLY DELIVERED. ON THE (B)(6) 2017, THE DEVICE WAS REPORTED AS BEING USED IN AN SCA EVENT. TWO SEPARATE EVENTS WERE RECORDED. THE FIRST EVENT WAS 3 MINUTES 43 SECONDS IN DURATION. THE PATIENT IMPEDANCE WAS OUT OF RANGE FOR THE DURATION OF THIS EVENT. THE ECG SUGGESTS THAT THE PATIENT WAS PRESENTING P-WAVE ASYSTOLE. AS THE IMPEDANCE WAS OUT OF RANGE, THE ALGORITHM DID NOT ASSESS THE PATIENT'S RHYTHM DURING THIS EVENT. SOME NOISE IN THE ECG SIGNAL WAS SEEN AT 00:02:19 TO 00:02:24, AND FROM 00:03:16 TO THE END OF THE EVENT. NO SIGNAL WAS RECORDED ON THE ICG TRACE THROUGHOUT THIS EVENT. THIS MAY BE DUE TO THE PAD-PAK BEING INCORRECTLY INSERTED, LEADING TO INSUFFICIENT POGO-PIN CONTACT. THE SECOND EVENT WAS 2 MINUTES 43 SECONDS IN DURATION. THE PATIENT IMPEDANCE WAS OUT OF RANGE FOR THE DURATION OF THIS EVENT. AT 00:00:03, THE ECG SUGGESTS THAT THE PATIENT WAS PRESENTING FINE VENTRICULAR FIBRILLATION. AS THE IMPEDANCE WAS OUT OF RANGE, THE ALGORITHM DID NOT ASSESS THE PATIENT'S RHYTHM DURING THIS EVENT. THE PATIENT THEN PRESENTED ASYSTOLE AT 00:00:49 BEFORE RETURNING TO FINE VENTRICULAR FIBRILLATION. A CARDIAC COMPLEX WAS SEEN AT 00:02:11. NO SIGNAL WAS RECORDED ON THE ICG TRACE THROUGHOUT THIS EVENT. THIS MAY BE DUE TO THE PAD-PAK BEING INCORRECTLY INSERTED, LEADING TO INSUFFICIENT POGO-PIN CONTACT. THE MEMORY LOG SHOWED THAT AT NO TIME DURING THE REPORTED SCA HAD THE DEVICE DETECTED AN IN-RANGE PATIENT IMPEDANCE. THIS MEANT THAT THE DEVICE DID NOT PROGRESS BEYOND THE ADVISORY SPEECH PROMPTS OF APPLY PADS TO PATIENT'S BARE CHEST AS SHOWN IN PICTURE. DURING THE INVESTIGATION, THE DEVICE WAS FOUND TO BE CORRECTLY MEASURING IMPEDANCE THROUGHOUT THE RANGE. THE REPORTED FAULT MAY HAVE BEEN BECAUSE OF POORLY PLACED ELECTRODE PADS OR AN INCORRECTLY INSTALLED PAD-PAK. THIS CONCLUSION IS FURTHER SUPPORTED BY THE DEVICE PERFORMING TO SPECIFICATION, WHEN PREVIOUSLY ATTACHED TO A PATIENT. ON THAT OCCASION, IMPEDANCES WERE MEASURED WITHIN RANGE THROUGHOUT THE SCA AND THE DEVICE SUCCESSFULLY ENTERED ANALYSING MODE BEFORE DELIVERING A 150J SHOCK.

    Description of Event or Problem · 0

    A PATIENT INVOLVED IN THIS EVENT. DEVICE KEPT PROMPTING TO CHECK PADS.

    Description of Event or Problem · 0

    A PATIENT WAS INVOLVED IN THIS EVENT. DEVICE KEPT PROMPTING APPLY PADS. IT WOULD NOT RECOGNISE THE PADS HAD BEEN APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357315 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1 Death