BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,350P,PP03,INTL EN,350-BAS-UK-10

    MDR report key: 8694986 · Received June 13, 2019

    Report

    Report Number
    3004123209-2019-00218
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    May 1, 2019
    Report Date
    August 30, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM350P
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 (B)(6)2016. UPON INVESTIGATION, THE DEVICE WAS WITNESSED SWITCHING ON AUTOMATICALLY, CONFIRMING THE REPORTED FAULT. THE FAULT WAS ATTRIBUTED TO MOISTURE AND CORROSION WITHIN THE DEVICE, WHICH WAS OBSERVED ON MANY CRITICAL CIRCUITS AND COMPONENTS, INCLUDING THE ON_BUTTON LINE OF THE MEMBRANE TAIL. ADDITIONALLY, THE MOISTURE OBSERVED ON STATUS LED CIRCUITRY AND MEMBRANE TAIL TRACKS HAD RESULTED IN BOTH STATUS LEDS CONSTANTLY ILLUMINATING ALONGSIDE A CONSTANT BEEP. FURTHERMORE, THE RETURNED PAD-PAK (EXPIRY NOVEMBER 2020) WAS FOUND TO BE DEPLETED BEYOND ANY USE. THIS WAS LIKELY A FURTHER CONSEQUENCE OF THE CONSTANTLY ILLUMINATED STATUS LEDS AND BEEP, WHICH WOULD HAVE RESULTED IN SIGNIFICANT EXCESS CURRENT DRAIN. IT IS UNCLEAR WHEN THE MOISTURE HAD INITIALLY PENETRATED THE DEVICE. HOWEVER, THE CORROSION OBSERVED ON THE MEMBRANE TAIL WOULD INDICATE THE DEVICE HAD BEEN IN THE PRESENCE OF MOISTURE FOR A PROLONGED PERIOD OF TIME. ADVISE USER 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 A POLICY OF HEARTSINE TO NOT REFURBISH DEVICES THAT HAVE BEEN RETURNED FROM THE FIELD, THEREFORE THIS DEVICE SHALL BE RETAINED AND REPLACED WITH A NEW SAM 350P.

    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

    WHEN PAD-PAK IS INSERTED THE DEVICE SWITCHES ON AUTOMATICALLY AND WILL NOT SWITCH OFF UNLESS PAD-PAK IS REMOVED. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    WHEN PAD-PAK IS INSERTED THE DEVICE SWITCHES ON AUTOMATICALLY AND WILL NOT SWITCH OFF UNLESS PAD-PAK IS REMOVED. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489047 PACKAGE,350P,PP03,INTL EN,350-BAS-UK-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1