BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 350P AND PAD-PAK

    MDR report key: 7172048 · Received January 8, 2018

    Report

    Report Number
    3004123209-2018-00007
    Event Type
    Malfunction
    Date Received
    January 8, 2018
    Date of Event
    December 1, 2017
    Report Date
    May 8, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P16008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). H3 OTHER TEXT: DEVICE NOT RETURNED YET.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE SAM 350P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. NO REWORK WAS CONDUCTED. THE SAM 350P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 24TH NOVEMBER 2016. A VISUAL INSPECTION OF THE DEVICE REVEALED NO APPARENT DEFECTS. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON THE 3RD JULY 2017 AND PERFORMED TO SPECIFICATION UP TO THE 26TH NOVEMBER 2017. UPON RECEIPT OF THE DEVICE, THE SPEECH PROMPTS WERE BARELY AUDIBLE, AS PER THE REPORTED FAULT. UPON VISUAL INSPECTION OF THE DEVICE SPEAKER, A BUILD-UP OF METALLIC DEBRIS WAS OBSERVED AROUND THE SPEAKER CONE, THIS HAD LIMITED THE AMPLITUDE OF THE SPEAKER AND RESULTING IN THE SPEECH PROMPTS BEING DELIVERED AT A MUCH LOWER VOLUME THAN ON A KNOWN GOOD DEVICE. THE DEVICE WAS RETESTED TO THE FINAL UNIT TEST SPECIFICATION, H032-014-004, DURING THE INVESTIGATION AND FAILED DUE TO A LOW VOLUME OF THE SPEECH PROMPTS, AND NONE OF THE PROCESSES IN HEARTSINE RESULT IN METALLIC DEBRIS. THEREFORE, THE INVESTIGATION CONCLUDES THIS ISSUE DEVELOPED AFTER DESPATCH FROM HEARTSINE. DUE TO THE MAGNETIC NATURE OF THE SPEAKER, THE METALLIC DEBRIS WOULD HAVE ENTERED THROUGH THE SPEAKER GRILLE FROM THE SURROUNDING ENVIRONMENT. THIS WOULD SUGGEST THE DEVICE HAD BEEN STORED IN THE PRESENCE OF METALLIC DEBRIS BY THE USER. 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 ANOTHER DEVICE OF THE SAME MODEL.

    Description of Event or Problem · 0

    THE DEVICE HAS LOW VOLUME WHEN PROMPTS PLAY. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    THE DEVICE HAS LOW VOLUME WHEN PROMPTS PLAY. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17280 HEARTSINE SAMARITAN 350P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1