BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,500P,PP03,FR,500-BAS-FR-10

    MDR report key: 8615013 · Received May 16, 2019

    Report

    Report Number
    3004123209-2019-00183
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    May 6, 2019
    Report Date
    June 24, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 500P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 500P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE (B)(6) 2016. NO FAULT WAS FOUND WITH THE RETURNED SAM 500P¿S ABILITY TO RECORD EVENT DATA. THE REPORTED ISSUE WAS DUE TO THE USER DOWNLOADING THE INCORRECT LOG ENTRY FROM SAVER EVO. THERE WERE TWO LOG ENTRIES FOR THE DATE OF THE REPORTED PATIENT INVOLVED EVENT ON THE (B)(6) 2019. THE FIRST OF THESE LOG ENTRIES LASTED ONLY A FEW SECONDS. THE SECOND LOG ENTRY LASTED APPROXIMATELY 19 MINUTES IN DURATION AND IS THEREFORE PRESUMABLE THE PATIENT INVOLVED EVENT. THE DISTRIBUTOR E-MAILED THE FIRST OF THESE LOG ENTRIES WITH THE COMPLAINT OF THE DEVICE FAILED TO RECORD THE PATIENT INVOLVED DATA. THE SAM 500P WAS STRESSED TESTED DURING THE COURSE OF THE INVESTIGATION WHILE PERFORMING SCHEDULED SELF-TESTS TEST OVER A PERIOD OF 48 HOURS. THE DEVICE SUCCESSFULLY RECORDED ALL DATA AND ALSO LOGGED THE SHOCK TESTING CARRIED OUT, CONFIRMING THE DATA. RECORDING FUNCTIONALITY. THIS COMPLAINT IS 1 OF 5 REPORTED BY A FRENCH DISTRIBUTOR FOR SAM 500P UNITS USED BY SDIS 29 FIRE AND RESCUE DEPARTMENT FOR INCONSISTENT DATA RECORDED DURING PATIENT INVOLVED EVENTS. NO FAULT HAS BEEN FOUND WITH ANY OF THE DEVICES. THIS WOULD INDICATE THE INCORRECT SAVER EVO FILE HAS BEEN DOWNLOADED BY THE DISTRIBUTOR FOR THESE EVENTS. THE USER ACCESSIBLE MEMORY LOG HAD BEEN ERASED FOR ALL THE SAM 500PS THEREFORE NO FURTHER INFORMATION WAS AVAILABLE TO REVIEW. THE DISTRIBUTOR HAS BEEN CONTACTED FOR FURTHER INFORMATION (SEE COMMUNICATION LOG). THIS DEVICE SHALL BY RETAINED BY HEARTSINE AS PER COMPLAINT HANDLING PROCEDURE (B)(4).

    Description of Event or Problem · 0

    ALLEGED MEMORY FAULT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    ALLEGED MEMORY FAULT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411017 PACKAGE,500P,PP03,FR,500-BAS-FR-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1