BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,350P,PP01,EN,350-BAS-US-10

    MDR report key: 8665956 · Received June 4, 2019

    Report

    Report Number
    3004123209-2019-00205
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 1, 2019
    Report Date
    August 19, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM350P
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 350P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 350P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 6TH FEBRUARY 2018. THE DEVICE PERFORMED TO SPECIFICATION DURING INVESTIGATION. NO FAULTS WERE FOUND ON THE DEVICE, INCLUDING MEASUREMENTS ON THE MEMBRANE AROUND THE GREEN STATUS LED AND THE RED STATUS LED . NO FAULT WAS FOUND ON THE STATUS LED LINES OF THE MEMBRANE, OR THEIR ASSOCIATED CIRCUITRY ON THE PCBA. THE TRACKS WERE INSPECTED FROM UNDERNEATH WITH NO ABNORMALITIES OBSERVED. ADDITIONALLY NO FAILS WERE LOGGED IN THE HISTORY LOG OF THE DEVICE. THE DEVICE WAS TEMPERATURE CYCLED FROM 0-50°C FOR 48 HOURS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. ADDITIONALLY, STRESS TESTING WAS CARRIED OUT AT 50°C 95%RH FOR 5 DAYS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. DURING THIS TIME THE GREEN STATUS LED FLASHED THROUGHOUT AND NO FAILURE CHIRP COULD BE HEARD FROM THE DEVICE. 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 ANOTHER DEVICE OF THE SAME MODEL.

    Description of Event or Problem · 0

    DEVICE PURCHASED A UNIT ONLY ABOUT 6 MONTHS AGO AND IT IS CHIRPING, BUT FLASHING GREEN. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    DEVICE PURCHASED A UNIT ONLY ABOUT 6 MONTHS AGO AND IT IS CHIRPING, BUT FLASHING GREEN. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461816 PACKAGE,350P,PP01,EN,350-BAS-US-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1