BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAD PAK 01

    MDR report key: 5729093 · Received June 16, 2016

    Report

    Report Number
    3004123209-2016-00792
    Event Type
    Malfunction
    Date Received
    June 16, 2016
    Date of Event
    June 7, 2016
    Report Date
    August 11, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K123881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. THE RETURNED PAD-PAK BOX HAD A LOT LABEL ATTACHED INDICATING THE PAD-PAK WAS PART OF LOT. A2199 [?]01-05-2020. THE RETURNED PAD-PAK WAS FOUND TO BE MISSING THE GREEN PULL TAB AND LOT AND EXPIRY LABEL. THIS WOULD CONFIRM THE REPORTED FAULT. THE DEVICE DHR STATES THE RETURNED PAD-PAK WAS MANUFACTURED AS PART OF LOT A2199 [?]01-05-2020 MANUFACTURED ON THE 7TH JANUARY 2016 AS PART OF 100 UNITS. THERE WERE NO RECORDED FAILS. INVESTIGATION FOUND THE GREEN PULL TAB AND LOT/EXPIRY LABEL WERE MISSING. THE INVESTIGATION WAS UNABLE TO DETERMINE CONCLUSIVELY WHETHER THE LABELS AND GREEN TAB WERE ORIGINALLY FITTED AND SUBSEQUENTLY REMOVED OR NEVER FITTED IN THE FIRST PLACE, HOWEVER A CUT IN THE PLASTIC COVERING FOR THE LABELS WAS OBSERVED HALFWAY DOWN THE REAR OF THE PAD-PAK, THIS MAY HAVE OCCURRED DURING OPENING OF THE OUTER CARDBOARD BOX, THIS MAY HAVE LED TO THE LABELS BEING REMOVED.

    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 : NOT YET RETURNED TO MANUFACTURER

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. PAD-PAK 01 IS MISSING GREEN PULL TAB AND LOT LABELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383257 PAD PAK 01 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD PAD-PAK N/A

    Patients

    Seq Age Sex Outcome Treatment
    1