BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,450P,PP01,EN,450-BAC-US-10

    MDR report key: 8780092 · Received July 11, 2019

    Report

    Report Number
    3004123209-2019-00253
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    July 1, 2019
    Report Date
    September 30, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM450P
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 450P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 450P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 15TH FEBRUARY 2019. UPON RECEIPT THE DEVICE WAS FAILING SELF- TESTS DUE TO A SPEECH CHIP LABEL MISMATCH ERROR. A FRACTURED SOLDER JOINT ON THE KEY3_BUTT ON LINE OF THE J12 CONNECTOR HAD RESULTED IN THE TRACK REMAINING OPEN CIRCUIT, LEADING TO THE FAILED SELF-TESTS. THE USER WOULD HAVE BEEN ALERTED WITH A ¿WARNING, DEVICE SERVICE REQUIRED¿ PROMPT ALONGSIDE A FLASHING RED STATUS LED AND FAILURE CHIRP, AS PER THE REPORTED FAULT. THE FAULT COULD NOT BE REPLICATED AFTER THE SOLDER JOINT WAS REFLOWED. THIS CONFIRMED THE FAILURE HAD BEEN DUE TO THE FRACTURED SOLDER JOINT. INFORMATION FROM HEARTSINE RECORDS AND THE DEVICE MEMORY INDICATE THE DEVICE HAD PERFORMED TO SPECIFICATION DURING OUT QAT ON THE 15TH FEBRUARY 2019 BUT FAILED ON INSTALLATION ON THE 7TH JULY 2019. THIS WOULD INDICATE THE SOLDER JOINT HAD BECOME FRACTURED BETWEEN THESE DATES. 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 NEW SAM 450P.

    Description of Event or Problem · 0

    DEVICE BEEPING RED STATUS INDICATOR. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    DEVICE BEEPING RED STATUS INDICATOR. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575599 PACKAGE,450P,PP01,EN,450-BAC-US-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD M727SAM450P

    Patients

    Seq Age Sex Outcome Treatment
    1