BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2932572 · Received January 23, 2013

    Report

    Report Number
    3004123209-2013-00118
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    August 3, 2011
    Report Date
    January 10, 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

    ON RECEIPT OF THE RETURNED PAD DEVICE AN ATTEMPT WAS MADE TO DOWNLOAD THE MEMORY, BUT IT WAS NOT POSSIBLE TO CONNECT THE DEVICE WITH A USB CABLE. "THE CONFIRMED THE FAULT". INSPECTION OF THE DEVICE REVEALED NO FAULTS. FURTHER INSPECTION OF THE PRINTED CIRCUIT BOARD REVEALED A POOR SOLDER JOINT ON THE USB MICROCHIP. THE SOLDER JOINT WAS REPAIRED AND THE CONNECTION OF THE PAD TO THE COMPUTER WAS NOW POSSIBLE. 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 PAD DEVICE WILL NOT CONNECT WITH AN USB CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33416 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1