BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,350P,PP03,NL,350-BAS-NL-10

    MDR report key: 7272523 · Received February 15, 2018

    Report

    Report Number
    3004123209-2018-00138
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    February 1, 2018
    Report Date
    June 18, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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.

    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. NO REWORK WAS CONDUCTED. THE SAM 350P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 25TH MAY 2017. BETWEEN THE 5TH DECEMBER 2017 AND THE 6TH DECEMBER 2017, INFORMATION FROM THE TECHNICAL LOG INDICATES THE SHOCK KEY HAD EITHER BEEN STUCK OR HELD DOWN, AS THE DEVICE RECORDS 8 FAILED SELF-TESTS DURING MANUAL POWER CYCLES, ALONGSIDE 5 SUCCESSFUL SELF-TESTS. THIS RESULTED IN THE DEVICE POWERING OFF WITH A FLASHING RED STATUS LED AND A ¿WARNING DEVICE SERVICE REQUIRED¿ MESSAGE ALONG WITH A FAILURE CHIRP, AS PER THE REPORTED FAULT. NO FAULT COULD BE MEASURED OR OBSERVED WITH THE SHOCK KEY LINE. THE DEVICE WAS TEMPERATURE CYCLED BETWEEN 0-50°C FOR 48 HOURS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES, THIS EQUATES TO APPROXIMATELY 33 MONTHS OF NORMAL OPERATION WITHOUT FAULT. THE FAULT WAS ONLY REPLICATED BY HOLDING IN THE SHOCK KEY DURING A SELF-TEST AT THE START OF A MANUAL POWER CYCLE. IT IS POSSIBLE AN INTERMITTENT FAULT WITH ONE OF THE COMPONENTS ON THE SHOCK KEY LINE, INCLUDING THE MEMBRANE, HAD RESULTED IN THE SHOCK KEY LINE BEING SHORTED TO GROUND AND THE FAILED SELF-TESTS OBSERVED IN THE HISTORY LOG, DESPITE BEING UNABLE TO MEASURE THIS DURING THE INVESTIGATION. ALTERNATIVELY, THE USER MAY HAVE MISTAKENLY PRESSED OR HELD THE SHOCK KEY DURING THE SELF-TESTS. IT IS THE POLICY OF HEARTSINE NOT TO REFURBISH DEVICES WHICH HAVE BEEN RETURNED FROM THE FIELD, AFTER INVESTIGATION, THEREFORE THIS DEVICE SHALL BE SCRAPPED AND REPLACED WITH ANOTHER DEVICE OF THE SAME MODEL. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT TESTING AT HEARTSINE.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. DEVICE SERVICE REQUIRED PROMPT ISSUED.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. DEVICE SERVICE REQUIRED PROMPT ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118096 PACKAGE,350P,PP03,NL,350-BAS-NL-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1