BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6586944 · Received May 24, 2017

    Report

    Report Number
    3004123209-2017-00495
    Event Type
    Malfunction
    Date Received
    May 24, 2017
    Date of Event
    May 4, 2017
    Report Date
    October 20, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    Z-00124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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 HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY BY THE USER ON (B)(6) 2008. AND THAT IT HAD SUCCESSFULLY PERFORMED ALL WEEKLY AUTO SELF-TESTS UP TO (B)(6) 2008. THROUGHOUT THE HISTORY LOG THE DEVICE RECORDS MULTIPLE OCCASIONS IN WHICH THE TEMPERATURE IS RECORDED OUTSIDE THE RECOMMENDED OPERATING RANGE OF 10-50°C FOR THE 2.0.2 SOFTWARE INSTALLED WITH A TEMPERATURE LOW OF -2.9°C RECORDED. THIS WOULD ACCOUNT FOR THE INITIAL LOW BATTERY FAILS DETAILED IN THE REPORT. INVESTIGATION FOUND THE FAULT CAN BE ATTRIBUTED TO A DEPLETED PAD-PAK. THE RETURNED PAD-PAK (LOT A2253 JUL2020) WAS MANUFACTURED ON THE 10TH MARCH 2016 AS PART OF A BATCH OF (B)(6) UNITS. THE DHR WAS INSPECTED WITH NO RECORDED FAILS. THE RETURNED PAD-PAK WAS DISASSEMBLED TO INVESTIGATE WITH ALL CELLS SHOWING A SIMILAR LEVEL OF DEPLETION. THE INVESTIGATION WAS UNABLE TO DETERMINE WHY THE RETURNED PAD-PAK WAS DEPLETED DESPITE HAVING AN EXPIRY DATE OF JULY 2020. THE UNIFORMED DEPLETION OF THE CELLS WOULD BE CONSISTENT WITH A PAD DEVICE DISPLAYING AN EXCESS CURRENT DRAIN/MEMBRANE FAILURE. NO FAULT OF THIS NATURE COULD BE FOUND WITH THE RETURNED DEVICE, THEREFORE GIVEN THAT NO FURTHER INFORMATION WAS AVAILABLE THE INVESTIGATION CONCLUDES THAT THE RETURNED PAD-PAK MAY NOT HAVE BEEN USED WITH THIS DEVICE. THE PAD-PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELLED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE.

    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. LOW BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370912 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1