BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 350P AND PAD-PAK

    MDR report key: 9179140 · Received October 11, 2019

    Report

    Report Number
    3004123209-2019-00363
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    September 26, 2019
    Report Date
    November 27, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM350P
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 350P DEVICE 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 30TH APRIL 2018. UPON RECEIPT THE LEFT PAD ICON LED FAILED TO ILLUMINATE, AS PER THE REPORTED FAULT. EXCESS SILICONE WAS OBSERVED THE MEMBRANE TAIL AND UPPER CASE, WHICH HAD POSITIONED THE TAIL AROUND A TIGHTER BEND AND LED TO A FRACTURE OF TRACK 2 (LEFT_PAD_LED). THIS HAD RESULTED IN AN INTERMITTENT CONNECTION ON THIS LINE. AS THE OPERATION OF THE LEFT PAD LED WAS VERIFIED DURING FINAL UNIT TEST, IT IS LIKELY THAT THE FRACTURE HAD DEVELOPED AFTER THIS TIME DUE TO ADDITIONAL STRESS ON THE MEMBRANE TAIL AT THIS POINT. THE ISSUE SHALL BE INVESTIGATED UNDER (B)(4). 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

    LED DO NOT WORK. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    LED DO NOT WORK. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977096 HEARTSINE SAMARITAN 350P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1