BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 7188815 · Received January 15, 2018

    Report

    Report Number
    3004123209-2018-00082
    Event Type
    Malfunction
    Date Received
    January 15, 2018
    Date of Event
    January 10, 2018
    Report Date
    March 20, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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: DEVICE NOT RETURNED YET.

    Description of Event or Problem · 0

    DEVICE WILL NOT SWITCH ON. NO PATIENT INVOLVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THE SAM 300P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. NO REWORK WAS CONDUCTED. THE SAM 300P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 17TH AUGUST 2011 THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY ON THE (B)(6) 2011 AND PERFORMED TO SPECIFICATION UP TO AND INCLUDING THE LAST LOG ENTRY ON THE (B)(6) 2017. C9 WAS MEASURED AND FOUND TO HAVE FAILED. C9 IS USED TO PREVENT THE 18V LINE DROPPING LOW DURING THE INITIAL CHARGE CYCLE. A BREAKDOWN OF C9 WOULD RESULT IN AN 18V SHORT TO GND. THIS WOULD THEN CAUSE AN INSTALLED PAD-PAK TO POTENTIALLY BLOW ITS FUSE AND THEREFORE APPEAR DEPLETED. DURING THE INVESTIGATION A TEST PAD-PAK WAS INSTALLED AND ALTHOUGH THE FAULT DID NOT CAUSE THE TEST PAD-PAK FUSE TO BLOW IT DID HAVE A SIGNIFICANT IMPACT ON THE VOLTAGE DUE TO THE EXCESS CURRENT DRAIN AND RESULTING IN THE DEVICE SHUTTING DOWN WITH A ¿WARNING, LOW BATTERY, DEVICE SERVICE REQUIRED¿ PROMPT AND A FLASHING RED STATUS LED. THE RETURNED PAD-PAK HAD A BLOWN FUSE, THIS COULD BE ATTRIBUTED TO THE FAILING C9 AND RESULTED IN THE REPORTED FAULT OF ¿WILL NOT SWITCH ON¿. THE FUNCTIONALITY OF THE CIRCUIT IS TESTED AT BOTH H017-014-103 PBA TEST AND H017-014-104 FINAL. THEREFORE, IT IS CONCLUDED THAT THE COMPONENT FAILED AFTER DISPATCH. THE DEVICE SUCCESSFULLY PASSED ALL WEEKLY AUTO SELF-TESTS UP TO THE 21ST MARCH 2017. IT IS ASSUMED THAT CAPACITOR C9 FAILED AFTER THIS.

    Description of Event or Problem · 1

    DEVICE WILL NOT SWITCH ON. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33559 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1