BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 450P AND PAD-PAK

    MDR report key: 7320172 · Received March 7, 2018

    Report

    Report Number
    3004123209-2018-00209
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    February 26, 2018
    Report Date
    May 29, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P16008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 450P 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 450P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 14TH MAY 2015. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT TESTING AT HEARTSINE. ON THE (B)(6) 2018, INFORMATION FROM THE TECHNICAL LOG INDICATES THE SHOCK KEY HAD EITHER BEEN ¿STUCK¿ OR HELD DOWN BY AN EXTERNAL FORCE, AS THE DEVICE RECORDS A FAILED WEEKLY AUTO SELF-TEST, AS PER THE REPORTED FAULT. THIS RESULTED IN THE DEVICE POWERING OFF WITH A FLASHING RED STATUS LED AND A ¿WARNING DEVICE SERVICE REQUIRED¿ MESSAGE ALONG WITH A FAILURE CHIRP. THE DEVICE WAS SUCCESSFULLY POWER CYCLED PASSING A SELF-TEST A DAY LATER. NO FAULT COULD BE MEASURED OR OBSERVED WITH THE SHOCK KEY LINE. THE DEVICE WAS TEMPERATURE CYCLED BETWEEN 0-50°C FOR 48 HOURS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES, THIS EQUATES TO APPROXIMATELY 33 MONTHS OF NORMAL OPERATION WITHOUT FAULT. THE FAULT WAS ONLY REPLICATED BY HOLDING IN THE SHOCK KEY DURING A SELF-TEST AT THE START OF A MANUAL POWER CYCLE. IT IS THE POLICY OF HEARTSINE NOT TO REFURBISH DEVICES WHICH HAVE BEEN RETURNED FROM THE FIELD, AFTER INVESTIGATION, THEREFORE THIS DEVICE SHALL BE SCRAPPED AND REPLACED WITH ANOTHER DEVICE OF THE SAME MODEL. DEVICE NOT RETURNED YET.

    Description of Event or Problem · 0

    SAM450P UNIT FAILS IT'S WEEKLY SELF TEST WITH PAD PAK EXPIRY 8-2021. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    SAM450P UNIT FAILS IT'S WEEKLY SELF TEST WITH PAD PAK EXPIRY 8-2021. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165474 HEARTSINE SAMARITAN 450P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1