BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY,PAD-PAK-01

    MDR report key: 8666030 · Received June 4, 2019

    Report

    Report Number
    3004123209-2019-00207
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 1, 2019
    Report Date
    July 30, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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).

    Additional Manufacturer Narrative · 0

    THE PAD-PAK WAS MANUFACTURED AS PART OF A LOT OF (B)(4) ON THE (B)(6)2017 . ALL PAD-PAK¿S WERE VOLTAGE TESTED ON THE (B)(6)2017 WITH ONE RECORDED FAIL. THE PAD-PAK WHICH FAILED WAS THEN STORED IN QUARANTINE. (B)(4) PAD-PAK UNITS WERE DISPATCHED TO ¿HST LLC¿ ON THE (B)(6)2017 . DAMAGE WAS OBSERVED ON THE LOCATOR PIN ON THE BATTERY TERMINAL SIDE OF THE RETURNED PAD-PAK (J0268 ¿(B)(6)2021).THIS DAMAGE IMPEDED THE INSERTION OF THE PAD-PAK WITHIN THE DEVICE AND RESULTED IN A DEVICE NOT POWERING ON.THE INVESTIGATION WAS UNABLE TO DETERMINE WHEN THE DAMAGE TO THE LOCATOR PIN OCCURRED BUT IF IT WAS PRESENT DURING THE INSTALLATION IT WOULD HAVE RESULTED IN THE REPORTED FAILURE. THE DAMAGE MAY HAVE BEEN CAUSED DURING AN INCORRECT INSTALLATION OF THE PAD-PAK. THE PAD-PAK WILL BE SCRAPPED AND REPLACED.

    Description of Event or Problem · 0

    NEW REPLACEMENT PAD-PAK OUT OF BOX FAILED TO START DEVICE BUT OLD PAD PAK STILL POWERED UP DEVICE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    NEW REPLACEMENT PAD-PAK OUT OF BOX FAILED TO START DEVICE BUT OLD PAD PAK STILL POWERED UP DEVICE.THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459412 BATTERY,PAD-PAK-01 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD J0268

    Patients

    Seq Age Sex Outcome Treatment
    1