BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5522647 · Received March 24, 2016

    Report

    Report Number
    3004123209-2016-00209
    Event Type
    Malfunction
    Date Received
    March 24, 2016
    Date of Event
    February 10, 2016
    Report Date
    March 23, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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). THE DEVICE DETAILED IN THIS REPORT WAS RETURNED TO HEARTSINE TECHNOLOGIES AS PART OF THE FSCA/RECALL Z-0124-2013 WITH NO ALLEGATION OF ANY FAULT WITH THE DEVICE. IT WAS THEREFORE INITIALLY ASSESSED AS NON-REPORTABLE HOWEVER SUBSEQUENT ENGINEERING INVESTIGATION REVEALED A FAULT WITH THE DEVICE WHICH WOULD CLASSIFY THE EVENT AS REPORTABLE. INVESTIGATION FOUND THE FAULT MAY BE ATTRIBUTED TO A SPEECH CHIP FAULT. THE ADULT PATIENT SPEECH PROMPT WAS NOT DELIVERED ON RECEIPT AT HEARTSINE AND THE DEVICE GAVE PROMPTS IN SPANISH RATHER THAN US ENGLISH SUGGESTING AN ATTEMPTED LANGUAGE CHANGE MAY HAVE TAKEN PLACE. THIS CAN CAUSE THE CHIP TO LOCK PREVENTING FURTHER PROGRAMMING. THE PAD-PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELED 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.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THIS DEVICE WAS RETURNED TO HEARTSINE TECHNOLOGIES AS PART OF THE CURRENT FSCA/RECALL, FDA REFERENCE Z-0124-2013. NO FAULT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180662 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1