BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2915088 · Received December 20, 2012

    Report

    Report Number
    3004123209-2012-00781
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 12, 2010
    Report Date
    December 11, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2010 BUT IT FAILED AN AUTO SELF TEST. THE VOLTAGE RECORDED AT THE TIME OF INSTALLATION WAS ZERO INDICATING A FAULTY CONNECTION BETWEEN THE PAD AND PAD-PAK. THE PROBLEM WAS ATTRIBUTED TO FAULTY POGO-PINS. THE POGO-PINS WERE TESTED AND SIGNIFICANT FLUCTUATIONS IN VOLTAGE WERE RECORDED. 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 PATIENT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE THE DEVICE WOULD NOT INITIALIZE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1