BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9402219 · Received December 3, 2019

    Report

    Report Number
    3004123209-2019-00424
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    November 1, 2019
    Report Date
    February 4, 2020
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM350P
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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 28TH FEBRUARY 2018. UPON RECEIPT OF THE DEVICE, THE DEVICE WAS UNABLE TO POWER ON AND NO STATUS INDICATOR WAS OBSERVED, AS PER REPORTED FAULTS. DURING DISASSEMBLY OF DEVICE, CORROSION AND MOISTURE INGRESS WAS EVIDENT ACROSS THE PCBA. CORROSION ACROSS THESE CIRCUITS WOULD HAVE RESULTED IN MULTIPLE FAILURE MODES INCLUDING BUT NOT LIMITED TO, THE DEVICE SWITCHING ON AUTOMATICALLY AND UNABLE TO POWER ON DEVICE. INFORMATION FROM THE HISTORY LOG SHOWS THE DEVICE PERFORMED TO SPECIFICATION UP TO THE 28TH JULY 2019. THIS WOULD INDICATE THE FAILURES HAD OCCURRED AFTER THIS DATE. THE USER SHOULD BE ADVISED OF THE RECOMMENDED STORAGE CONDITIONS AS DETAILED WITHIN THE USER MANUAL AS BEING LOCATED IN A CLEAN, DRY ENVIRONMENT AT A TEMPERATURE BETWEEN 0 TO 50°C AND 5 TO 95% RELATIVE HUMIDITY (NON-CONDENSING). 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.

    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

    THERE IS NO FLASHING, NO INDICATOR, AND NO POWER. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    THERE IS NO FLASHING, NO INDICATOR, AND NO POWER. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201546 PACKAGE,350P,PP01,EN,350-BAS-US-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM 350P M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1