BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY,PAD-PAK-01

    MDR report key: 8627064 · Received May 21, 2019

    Report

    Report Number
    3004123209-2019-00196
    Event Type
    Malfunction
    Date Received
    May 21, 2019
    Date of Event
    May 1, 2019
    Report Date
    September 16, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE PAD-PAK LOT WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE PAD-PAK WAS MANUFACTURED AS PART OF A LOT OF (B)(4) ON THE 1ST JUNE 2016, 195 OF WHICH WERE DISPATCHED TO HST INC ON THE 7TH JUNE 2016. ALL PAD-PAK¿S WERE SUBJECT TO A BATTERY VOLTAGE TEST ON THE 2ND JUNE 2016, WITH NO RECORDED FAILS. UPON INVESTIGATION, MEASUREMENTS TAKEN ON THE PAD-PAK CONFIRMED THE BATTERIES TO BE DEPLETED BEYOND ANY USE. THE CUSTOMER EMAIL ATTACHED IN ¿COMMUNICATION LOG ¿ 2ND CONTACT.MSG¿ DETAILS THAT THE RETURNED PAD-PAK WAS USED IN A SAM 300 DEVICE (SN: 0700023316), WHICH WAS PRESENTING A FAULT ON THE ON/OFF FUNCTIONALITY. THE SERIAL NUMBER OF THE DEVICE FALLS WITHIN THE RANGE COVERED BY AN FSCA. AS PER Q017-CAPA-131 AND IN ACCORDANCE WITH THE FSCA DEFINED BY H007-003-001 AND FDA REFERENCE Z-0124-2013, EXPERIENCE HAS SHOWN THAT IT IS REASONABLE TO CONCLUDE THAT DEVICE SWITCHING ON AUTOMATICALLY MAY BE ATTRIBUTED TO MEMBRANE FAILURE. THE REPORTED CUSTOMER FAULT MAY BE RELATED TO THIS FAILURE MODE AND THEREFORE RESULTED IN THE DEPLETION OF THE RETURNED PAD-PAK. THE CUSTOMER HAS BEEN ADVISED TO REMOVE THE SAM 300 FROM SERVICE.

    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

    PAD-PAD LOT A2342 DEPLETED BEFORE EXPIRY2020-10-01. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    PAD-PAD LOT A2342 DEPLETED BEFORE EXPIRY2020-10-01. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421805 BATTERY,PAD-PAK-01 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD A2342

    Patients

    Seq Age Sex Outcome Treatment
    1