BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2932519 · Received January 23, 2013

    Report

    Report Number
    3004123209-2013-00051
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    July 31, 2008
    Report Date
    January 4, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE NO EVENTS RECORDED IN THE RETURNED PAD DEVICE AND THE DEVICE LOG APPEARS CORRUPT CONFIRMING THE COMPLAINT. THE DEVICE WAS DISASSEMBLED AND IT AN INSUFFICIENT SOLDER ON THE FLASH MEMORY CHIP, U24 WAS REVEALED. THE SOLDER JOINT WAS REPAIRED AND THE DEVICE OPERATED AS EXPECTED AND RECORDED PROPERLY. THE SOLDER JOINT LIKELY DETERIORATED OVER TIME. THE PAD PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE.

    Description of Event or Problem · 1

    THERE WAS NO PT INVOLVED IN THIS EVENT. THE DEVICE MALFUNCTIONED BECAUSE THE DEVICE WAS NOT RECORDING ANY EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33404 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1