BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_MEDICAL - BELFAST_PRODUCT

    MDR report key: 7111956 · Received December 13, 2017

    Report

    Report Number
    3004123209-2017-01499
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    November 1, 2017
    Report Date
    January 12, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAM 300P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 17TH SEPTEMBER 2010. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY BY THE USER ON THE (B)(6) 2010. MULTIPLE MANUAL POWER UPS OF TEN MINUTES DURATION WERE OBSERVED IN THE DEVICE MEMORY BETWEEN THE 6TH OCTOBER 2017 AND THE 11TH OCTOBER 2017. THE RANDOM NATURE OF THE EVENTS STORED IN THE MEMORY AND THE 10 MINUTE TIME OUTS, WOULD SUGGEST A FAILING MEMBRANE. EXPERIENCE HAS SHOWN THAT IT IS REASONABLE TO CONCLUDE THAT THESE SYMPTOMS MAY BE ATTRIBUTED TO A MEMBRANE FAILURE

    Additional Manufacturer Narrative · 0

    THE SAM 300P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 17TH SEPTEMBER 2010. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY BY THE USER ON THE (B)(6) 2010. MULTIPLE MANUAL POWER UPS OF TEN MINUTES DURATION WERE OBSERVED IN THE DEVICE MEMORY BETWEEN THE 6TH OCTOBER 2017 AND THE 11TH OCTOBER 2017. THE RANDOM NATURE OF THE EVENTS STORED IN THE MEMORY AND THE 10 MINUTE TIME OUTS, WOULD SUGGEST A FAILING MEMBRANE. EXPERIENCE HAS SHOWN THAT IT IS REASONABLE TO CONCLUDE THAT THESE SYMPTOMS MAY BE ATTRIBUTED TO A MEMBRANE FAILURE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. DEVICE DISPLAYING SWITCHING ON AUTOMATICALLY SYMPTOM.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. DEVICE DISPLAYING SWITCHING ON AUTOMATICALLY SYMPTOM.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. DEVICE DISPLAYING SWITCHING ON AUTOMATICALLY SYMPTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892582 UNKNOWN_MEDICAL - BELFAST_PRODUCT AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1