BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5569699 · Received April 12, 2016

    Report

    Report Number
    3004123209-2016-00460
    Event Type
    Malfunction
    Date Received
    April 12, 2016
    Date of Event
    April 4, 2016
    Report Date
    June 8, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). ON RECEIPT OF THE DEVICE THE HISTORY AND MEMORY LOGS WERE DOWNLOADED. THE HISTORY LOG SHOWED THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY ON (B)(6) 2013 PASSING A SELF-TEST. THE PAD-PAK WAS THEN REMOVED AND REINSTALLED ON MULTIPLE OCCASIONS BETWEEN (B)(6) 2013 AND (B)(6) 2016. THE DEVICE FAILED A SELF-TEST DUE TO A LOW BATTERY ON (B)(6) 2016. SEVERAL LOG ENTRIES ARE RECORDED CONTAINING NONSENSICAL DATA. THIS MAY INDICATE THE PAD-PAK WAS INCORRECTLY SEATED IN THE DEVICE OR THAT THE PAD-PAK WAS DEPLETED BEYOND FUNCTIONAL USE. THE RETURNED PAD-PAK WAS INSERTED INTO THE DEVICE AND FAILED TO POWER ON. THE RED STATUS LED ILLUMINATED ALONG WITH A FAILURE CHIRP. THIS WOULD CONFIRM THE REPORTED FAULT. A TEST PAD-PAK WAS INSERTED AND THE DEVICE PASSED A SELF-TEST. INVESTIGATION FOUND THE RETURNED PAD-PAK WAS DEPLETED BEYOND FUNCTIONAL USE. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT TESTING AT HEARTSINE. THIS RESULTED IN THE DEVICE DISPLAYING A FLASHING RED LED AND FAILURE CHIRP. INVESTIGATION WAS UNABLE TO DETERMINE HOW THE PAD-PAK BECAME DEPLETED. THE BATTERY MONITORING CIRCUITRY WAS VERIFIED DURING THE INVESTIGATION AND THE DEVICE TEMPERATURE CYCLED BETWEEN 0-50 DEGREES CELSIUS FOR 48 HOURS. THIS EQUATES TO APPROXIMATELY 33 MONTHS OF NORMAL OPERATION WITHOUT FAULT.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058 HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). H3 OTHER TEXT : NOT YET RETURNED TO MANUFACTURER

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. PAD UNIT HAS FLASHING RED STATUS INDICATOR LIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226665 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1