BEUDAMED
    FDA Adverse Event Death Summary report: N

    PACKAGE,350P,PP03,PL,350-BAS-PO-10

    MDR report key: 7250640 · Received February 8, 2018

    Report

    Report Number
    3004123209-2018-00127
    Event Type
    Death
    Date Received
    February 8, 2018
    Date of Event
    January 2, 2018
    Report Date
    April 26, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P160008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THERE WAS A PATIENT INVOLVED HOWEVER WAS NOT IMPACTED BY THE EVENT DURING POST MARKET SURVEILLANCE IT WAS OBSERVED THAT THERE WAS A BREAK IN MEMORY RECORDING.

    Additional Manufacturer Narrative · 1

    EXECUTIVE SUMMARY: A SPIKE OF UNKNOWN ORIGIN WAS VISIBLE IN THE ECG TRACE, SHORTLY AFTER THE SHOCK WAS DELIVERED, WHICH LED TO A RECOMMENDATION FOR THE DEVICE HARDWARE TO BE INVESTIGATED. 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 18TH AUGUST 2015. A VISUAL INSPECTION OF THE DEVICE REVEALED NO APPARENT DEFECTS. THE DEVICE HISTORY AND MEMORY LOGS WERE DOWNLOADED AND ARE ATTACHED TO THIS REPORT. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY ON THE 28TH DECEMBER 2015 AND PERFORMED TO SPECIFICATION UP TO AND INCLUDING THE 17TH DECEMBER 2017. THE DEVICE WAS USED DURING AN SCA ON THE 18TH DECEMBER 2017. HEARTSINE WERE CONTACTED AND PROVIDED WITH DETAILS OF THE SCA AS PART OF POST MARKET DATA. THE INITIAL REVIEW WAS CONDUCTED UNDER (B)(4). A SUCCESSFUL 150J SHOCK WAS DELIVERED DURING THE EVENT. A SPIKE OF UNKNOWN ORIGIN WAS VISIBLE IN THE ECG TRACE, SHORTLY AFTER THE SHOCK WAS DELIVERED, WHICH LED TO A RECOMMENDATION FOR THE DEVICE HARDWARE TO BE INVESTIGATED IN THE ABSENCE OF THE PATIENT, AND NO FAULT FOUND WITH THE DEVICE, THE ECG/ICG SPIKE DURING THE EVENT MAY HAVE BEEN DUE TO EXTERNAL INTERFERENCE I.E. MOVEMENT OF THE ELECTRODE PADS, TOUCHING OF THE PATIENT, ELECTROMAGNETIC INTERFERENCE OR USE WITH A SECONDARY AED. A SCENARIO WHERE A SECONDARY AED WAS USED, DURING THE CPR PHASE, DID REPLICATE THE SPIKE SEEN ON THE ECG/ICG TRACE OF THE REPORTED SCA. HOWEVER, THERE IS NO FURTHER EVIDENCE TO SUGGEST A SECONDARY AED WAS USED. THIS DEVICE SHALL BY RETAINED BY HEARTSINE AS PER COMPLAINT HANDLING PROCEDURE (B)(4).

    Description of Event or Problem · 1

    THERE WAS A PATIENT INVOLVED HOWEVER WAS NOT IMPACTED BY THE EVENT DURING POST MARKET SURVEILLANCE IT WAS OBSERVED THAT THERE WAS A BREAK IN MEMORY RECORDING. (ADDITIONAL INFORMATION): A SPIKE OF UNKNOWN ORIGIN WAS VISIBLE IN THE ECG TRACE, SHORTLY AFTER THE SHOCK WAS DELIVERED, WHICH LED TO A RECOMMENDATION FOR THE DEVICE HARDWARE TO BE INVESTIGATED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98750 PACKAGE,350P,PP03,PL,350-BAS-PO-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1