BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY,PAD-PAK-03

    MDR report key: 10412344 · Received August 17, 2020

    Report

    Report Number
    3004123209-2020-00264
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Date of Event
    July 23, 2020
    Report Date
    October 12, 2020
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DHR FOR PAD-PAK LOT J0787 WAS REVIEWED, WHICH REVEALED THE RETURNED PAD-PAK WAS 1 OF (B)(4) MANUFACTURED ON THE 10TH JUNE 2020, 214 OF WHICH WERE SHIPPED TO STRYKER VENLO ON THE 11TH JUNE 2020. ALL PAD-PAKS WERE TESTED WITH RESPECT TO ELECTRODE CAPACITANCE AND BATTERY VOLTAGE ON THE 11 JUNE 2020. NO PAD-PAKS FAILED THE ELECTRODE TEST. THE CUSTOMER REPORTED THAT A WIRE WAS TRAPPED BETWEEN THE PAD-PAK PLASTICS UPON RECEIPT. UPON INVESTIGATION AT HEARTSINE, NO TRAPPED CABLES WERE OBSERVED AND THE ELECTRODE TRAY WAS CORRECTLY INSERTED. HOWEVER, A MORE PRONOUNCED BEND WAS OBSERVED IN THE STERNUM CABLE, WHICH MAY SUGGEST THE CABLE HAD INITIALLY BEEN TRAPPED WITHIN THE PAD-PAK, BEFORE BEING RELEASED BY THE USER UPON REMOVAL OF THE ELECTRODE TRAY. DURING THE INVESTIGATION, THE PAD-PAK DELIVERED SHOCK THERAPY WITHOUT FAULT WITH THE PADS STILL ATTACHED, AND NO CONTINUITY ISSUE WAS IDENTIFIED ACROSS EITHER PATIENT CABLE. THIS WOULD INDICATE THE REPORTED ISSUE WAS COSMETIC IN NATURE. PAD-PAK OPERATORS SHALL BE MADE AWARE OF THIS ISSUE AS PER (B)(4).

    Description of Event or Problem · 0

    ELECTRODE WIRES FOUND CAUGHT BETWEEN PAD-PAK TRAY AND BODY ON A NEW OUT OF BOX PAD-PAK-03. THERE WAS NO PATIENT INVOLVED IN TIS EVENT.

    Description of Event or Problem · 1

    ELECTRODE WIRES FOUND CAUGHT BETWEEN PAD-PAK TRAY AND BODY ON A NEW OUT OF BOX PAD-PAK-03. THERE WAS NO PATIENT INVOLVED IN TIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876293 BATTERY,PAD-PAK-03 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD J0787

    Patients

    Seq Age Sex Outcome Treatment
    1