BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 8619006 · Received May 17, 2019

    Report

    Report Number
    3004123209-2019-00195
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    May 1, 2019
    Report Date
    July 1, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 300P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 300P PASSED ¿OUT QAT¿ FROM HEARTSINE TECHNOLOGIES ON THE (B)(6) 2013. SILVER PASTE SHORT CIRCUIT ON MEMBRANE. DURING THE INVESTIGATION, THE STATUS LED WAS OBSERVED TO BE FLASHING GREEN AND BEEPING, THIS WOULD CONFIRM THE REPORTED FAULT. THIS IS DUE TO A SHORT CIRCUIT BETWEEN THE ANODE AND CATHODE OF THE RED STATUS LED RESULTING IN LEAKAGE CURRENT TO BEEPER BP1. 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 KNOWN GOOD MEMBRANE FITTED. 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 HAS GREEN STATUS INDICATOR BUT BEEPS. PAD-PAK J0540 EXPIRY 2023-02-01. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    DEVICE HAS GREEN STATUS INDICATOR BUT BEEPS. PAD-PAK J0540 EXPIRY: 02/01/2023. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414818 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1