BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2915272 · Received December 19, 2012

    Report

    Report Number
    3004123209-2012-00444
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 21, 2012
    Report Date
    December 17, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL TESTING OF THIS DEVICE REVEALED THAT THE DEVICE WOULD NOT CONNECT TO (B)(4) SOFTWARE. THE DEVICE WAS DISASSEMBLED AND IT WAS CONFIRMED THAT THE SCREW FOR THE +VE TERMINAL ON THE USB CABLE HAD BECOME LOOSE AND HAD FALLEN OUT. THE INFO OBTAINED FROM THE DEVICE REVEALED THAT IT HAD PERFORMED TO SPECIFICATION FROM (B)(6) 2008. TESTING CONCLUDED THAT THE DEVICE WAS ABLE TO PERFORM TO SPECIFICATION AND THAT THE MISSING SCREW WOULD NOT HAVE PREVENTED THE DEVICE FROM PERFORMING AS INTENDED DURING A SUDDEN CARDIAC ARREST (SCR). 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. THIS DEVICE WAS REPORTED BECAUSE THE END USER NOTICED THAT THERE WAS SOMETHING LOOSE INSIDE THE DEVICE.

    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