BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,360P,PP03,INTL EN,360-BAS-UK-10

    MDR report key: 8702977 · Received June 17, 2019

    Report

    Report Number
    3004123209-2019-00230
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    June 1, 2019
    Report Date
    September 30, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 360P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 360P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 17TH AUGUST 2018. THE DHR FOR PAD-PAK LOT A2964 WAS REVEALED, WHICH REVEALED THE RETURNED PAD-PAK WAS 1 OF (B)(4) MANUFACTURED ON THE 15TH AUGUST 2018. ALL PAD-PAKS WERE SUBJECT TO BATTERY VOLTAGE TESTING ON THE 16TH AUGUST 2018, WITH NO RECORDED FAILS. 08/17/2018 UPON RECEIPT, SIGNIFICANT MOISTURE AND CORROSION WAS OBSERVED WITHIN THE DEVICE, ACROSS MANY CRITICAL CIRCUITS AND COMPONENTS OF THE SAM 360P, INCLUDING THE ON/OFF CIRCUITRY, THE CHARGING CIRCUITRY AND THE MEMBRANE TAIL, WHICH WOULD HAVE RESULTED IN MULTIPLE FAILURE MODES. INVESTIGATION OF THE RETURNED PAD-PAK REVEALED ITS CELLS WERE FAILING UNDER LOAD, CAUSING THE DEVICE INSTRUCTIONAL LEDS TO FLASH RAPIDLY ALONGSIDE AN AUDIBLE CLICK FROM THE SPEAKER, AS PER THE REPORTED FAULTS. GIVEN THE EXTENT OF THE MOISTURE AND CORROSION WITHIN THE DEVICE AND THE FAILURE OF THE PAD-PAK, IT IS LIKELY THE PAD-PAK BEEN STORED WITH THE DEVICE AND HAD THEREFORE FAILED AS A RESULT OF ADVERSE STORAGE CONDITIONS. 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 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 360P.

    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 CLICKING AND LEDS FLASHING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    DEVICE CLICKING AND LEDS FLASHING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496765 PACKAGE,360P,PP03,INTL EN,360-BAS-UK-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1