BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8243841 · Received January 14, 2019

    Report

    Report Number
    3004123209-2019-00032
    Event Type
    Malfunction
    Date Received
    January 14, 2019
    Date of Event
    January 1, 2019
    Report Date
    June 24, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM350P
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 (B)(6) 2018. THE DEVICE WAS RETURNED WITH THE REPORTED FAULT OF ¿DEVICE BEEPING¿. THE FAULT WAS CONFIRMED DURING THE INVESTIGATION AND WAS TRACED BACK TO A SHORT CIRCUIT BETWEEN THE CATHODE OF THE GREEN STATUS LED AND THE CATHODE OF THE RED STATUS LED. THE SHORT CIRCUIT HAD RESULTED IN THE DEVICE DISPLAYING A RED STATUS LED ALONG WITH A FAILURE CHIRP DESPITE NO SELF-TEST FAILS RECORDED IN THE HISTORY LOG AS PER REPORTED FAULT. THE FAULT WAS REPLICATED WITH USE OF A KNOWN GOOD MEMBRANE AND WIRE LINK.THE STATUS LED¿S ARE TESTED DURING H017-014-104 FINAL TEST. THEREFORE, IT IS CONCLUDED THAT THE SHORT CIRCUIT WAS INTERMITTENT IN NATURE AND CAUSED AS A RESULT OF AN OVER APPLICATION OF SILVER PASTE DURING THE MANUFACTURING PROCESS. THE SHORT CIRCUIT WAS SEEN ON THE MEMBRANE. THE FAULT COULD NOT BE REPLICATED WITH A NEW MEMBRANE FITTED.THE DEVICE WAS STILL ABLE TO DELIVER THE TEST THERAPY SEQUENCE WITHOUT FAULT DURING TESTING AT HEARTSINE. 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 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

    DEVICE BEEPING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    DEVICE BEEPING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37959 PACKAGE,350P,PP01,EN,350-BAS-US-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1