BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 350P AND PAD PAK

    MDR report key: 7016922 · Received November 10, 2017

    Report

    Report Number
    3004123209-2017-01396
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    November 8, 2017
    Report Date
    December 20, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P16008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). THE DEVICE HISTORY RECORDS FOR THE RETURNED SAM 350P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE DESPATCH OF THE SAM 350P FROM HEARTSINE TECHNOLOGIES, BELFAST ON THE 22ND JULY 2015. ON RECEIPT OF THE DEVICE THE HISTORY AND MEMORY LOGS COULD NOT BE DOWNLOADED. THE DEVICE WAS DISASSEMBLED FOR FURTHER INVESTIGATION. UPON VISUAL INSPECTION OF THE PCBA, CORROSION WAS OBSERVED ON TRACKS OF THE MEMBRANE TAIL. THE CORROSION OBSERVED WOULD INDICATE THE DEVICE HAD BEEN SUBJECT TO MOISTURE INGRESS. A FAILED MICROPROCESSOR WAS ALSO FOUND. THROUGHOUT THE HISTORY LOG THE DEVICE RECORDS ONE OCCASION IN WHICH THE TEMPERATURE IS RECORDED OUTSIDE THE RECOMMENDED OPERATING RANGE OF 0-50°C WITH A LOW OF -2.3°C RECORDED. THIS, ALONG WITH THE CORROSION OBSERVED ON THE MEMBRANE TAIL, WOULD INDICATE THE DEVICE WAS STORED IN ADVERSE CONDITIONS. THE PAD-PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELLED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE, WHICH IS WHY THE "UNKNOWN" BOX HAS BEEN CHECKED IN \THIS REPORT. THE PAD-PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELLED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE WILL NOT SWITCH ON WITH NEW PAD-PAK AND WILL NOT CONNECT TO SAVER EVO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796244 HEARTSINE SAMARITAN 350P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1