BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 500P AND PAD PAK

    MDR report key: 6841375 · Received September 5, 2017

    Report

    Report Number
    3004123209-2017-00999
    Event Type
    Malfunction
    Date Received
    September 5, 2017
    Date of Event
    August 23, 2017
    Report Date
    October 26, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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). THE DEVICE HISTORY RECORDS FOR THE RETURNED SAM 500P DEVICE WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE DESPATCH OF THE SAM 500P FROM HEARTSINE TECHNOLOGIES, BELFAST ON 19TH DECEMBER 2014. ON RECEIPT OF THE DEVICE THE HISTORY AND MEMORY LOGS WERE DOWNLOADED. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON (B)(6) 2015 AND PERFORMED TO SPECIFICATION UP UNTIL (B)(6) 2017. THROUGHOUT THE HISTORY LOG THE DEVICE RECORDS 125 MANUAL POWER UPS, ALL UNDER ONE-MINUTE DURATION. THE MAJORITY OF THESE POWER UPS OCCURRED DURING THE WORKING WEEK. THE RETURNED PAD-PAK WAS INSERTED INTO THE DEVICE. THE DEVICE SUCCESSFULLY PASSED AN AUTO SELF-TEST THEN PASSED A SELF-TEST DURING A MANUAL POWER CYCLE. A "WARNING MEMORY FULL" MESSAGE WAS GIVEN AT SHUTDOWN AND THE STATUS LED CONTINUED TO FLASH GREEN. AFTER FURTHER INVESTIGATION THE REPORTED FAULT WAS UNABLE TO BE REPLICATED. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT TESTING AT HEARTSINE. DEVICES RETURNED FOR SWITCHING ON AUTOMATICALLY NORMALLY HAVE SYMPTOMS INCLUDING AN EXCESS CURRENT DRAIN AND MULTIPLE MANUAL POWER UPS MAINLY OF TEN-MINUTE DURATION. THE CURRENT DRAIN OF THE DEVICE WAS WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE SWITCHING ON AUTOMATICALLY, MEMORY FULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621199 HEARTSINE SAMARITAN 500P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1