BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8590286 · Received May 8, 2019

    Report

    Report Number
    3004123209-2019-00162
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    April 1, 2019
    Report Date
    July 11, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM450P
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    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 8TH MAY 2015. INFORMATION FROM THE DEVICE MEMORY SHOWS THE DEVICE HAD BEEN INSTALLED AND SUCCESSFULLY POWER CYCLED ON THE 21ST MARCH 2018 AND PERFORMED SUCCESSFULLY WEEKLY AUTO SELF-TESTS UP TO THE 25TH NOVEMBER 2018. THERE WAS THEN ONE FURTHER LOG ENTRY PRIOR TO RECEIPT AT HEARTSINE, RECORDED ON THE 18TH JANUARY 2019 DURING AN AUTO SELF-TEST. THE RETURNED PAD-PAK (LOT A3144 2023-05-01) WAS ONLY DISPATCHED FROM HEARTSINE ON THE 16TH JANUARY 2019. THE REPORTED ISSUE THEREFORE RELATES TO THE USER BEING UNABLE TO INSTALL THIS NEW PAD-PAK WITHIN THE DEVICE. DURING INVESTIGATION, DEVICE WAS SUCCESSFULLY POWER CYCLED MULTIPLE TIMES THROUGHOUT THE INVESTIGATION WITH THE RETURNED PAD-PAK INSTALLED. FURTHERMORE, NO MEASURABLE FAULT WAS IDENTIFIED ON THE UNIT AND NO ABNORMALITIES WERE FOUND ON THE PAD-PAK WHICH WOULD IMPEDE ITS INSTALLATION. THE PAD-PAK MAY THEREFORE HAVE BEEN INCORRECTLY SEATED WITHIN THE DEVICE DURING INSTALLATION. THE DEVICE WAS TEMPERATURE CYCLED BETWEEN 0-50°C WITH THE RETURNED PAD-PAK INSTALLED FOR 48 HOURS. ADDITIONAL STRESS TESTING WAS CARRIED OUT AT 50°C 95%RH WHILE PERFORMING SELF-TESTS FOR 5 DAYS. THIS COMBINED TESTING EQUATES TO APPROXIMATELY 9.5 YEARS OF NORMAL USE WITHOUT FAULT. 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.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).

    Description of Event or Problem · 0

    DEVICE WILL NOT SWITCH ON WITH NEW PAD-PAK 01 A3144. NO STATUS INDICATOR OR LEDS. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    DEVICE WILL NOT SWITCH ON WITH NEW PAD-PAK 01 A3144. NO STATUS INDICATOR OR LEDS. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386304 PACKAGE,450P,PP01,EN,450-BAC-US-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD M727SAM450P

    Patients

    Seq Age Sex Outcome Treatment
    1