BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7676668 · Received July 11, 2018

    Report

    Report Number
    3004123209-2018-00444
    Event Type
    Malfunction
    Date Received
    July 11, 2018
    Date of Event
    June 28, 2018
    Report Date
    August 29, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM350P
    PMA / PMN Number
    P160008
    Product Problem
    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 BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 350P DEVICE WAS 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 29TH NOVEMBER 2016. INCONCLUSIVE. UPON RECEIPT AT HEARTSINE, THE DEVICE MEMORY WAS FOUND TO CONTAIN MULTIPLE MANUAL POWER ONS, INCLUDING FOUR LOG ENTRIES RECORDING A SHOCK BUTTON STUCK ERROR, BETWEEN THE 10TH JUNE 2018 AND THE 2ND JULY 2018. THE USER WOULD HAVE BEEN ALERTED WITH A ¿WARNING, DEVICE SERVICE REQUIRED¿ PROMPT AS PER THE REPORTED FAULT, ALONGSIDE A FLASHING RED STATUS LED. NO FAULT WAS MEASURED ON THE SHOCK KEY LINE. THE DEVICE WAS TEMPERATURE CYCLED BETWEEN 0-50°C FOR 48 HOURS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. ADDITIONAL STRESS TESTING WAS CARRIED OUT AT 50°C 95%RH FOR 5 DAYS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. THIS COMBINED TESTING EQUATES TO APPROXIMATELY 9.5 YEARS OF NORMAL USE WITHOUT FAULT. THE OPERATION OF THE SHOCK BUTTON WAS VERIFIED AT DIFFERENT STAGES DURING THIS PERIOD. THE REPORTED FAULT COULD ONLY BE REPLICATED BY HOLDING THE SHOCK BUTTON DURING POWER ON. GIVEN THAT NO MEASURABLE FAULT WAS FOUND ON THE DEVICE, THE REPORTED FAULT MAY HAVE OCCURRED DUE TO AN EXTERNAL FORCE BEING APPLIED TO THE SHOCK BUTTON DURING POWER ON. 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 A SAM 350P.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. DEVICE SERVICE REQUEST PROMPT.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. DEVICE SERVICE REQUEST PROMPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519125 PACKAGE,350P,PP03,PL,350-BAS-PO-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1