BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,350P,PP03,DE,350-BAS-DE-10

    MDR report key: 8614745 · Received May 16, 2019

    Report

    Report Number
    3004123209-2019-00179
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    May 1, 2019
    Report Date
    July 1, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 350P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 350P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE (B)(6) 2017. UPON RECEIPT OF THE DEVICE AT HEARTSINE, THE PAD CLOCK DISPLAYED A NONSENSICAL DATE AND TIME AND WAS FAILING TO INCREMENT. MEASUREMENTS TAKEN ON MOSFET Q43 CONFIRMED THE COMPONENT HAD FAILED, WHICH HAD RESULTED IN A HIGH CURRENT DRAIN AND THE SUBSEQUENT DEPLETION OF THE BT1 COIN CELL, WHICH POWERS THE RTC. THIS HAD LED TO THE FAILURE OF THE CLOCK TO INCREMENT AND THE MULTIPLE SELF-TEST FAILS DUE TO AN RTC TICK TEST ERROR. THE USER WOULD HAVE BEEN ALERTED WITH ¿WARNING, DEVICE SERVICE REQUIRED¿ PROMPTS AS PER THE REPORTED FAULT. FURTHERMORE, AS THE BT1 COIN CELL PROVIDES THE POWER FOR THE STATUS LED DRIVE CIRCUITRY, THE DEPLETED CELL WOULD ALSO HAVE RESULTED IN THE ABSENCE OF ANY STATUS LED, AS PER THE ADDITIONAL REPORTED FAULT. Q43 AND THE COIN CELL WERE REPLACED, AND THE PAD CLOCK SYNCHRONISED. THE DEVICE WAS THEN LEFT IN THE HUMIDITY CHAMBER AT 50°C 95%RH FOR 5 DAYS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. NO SIGNIFICANT CHANGE IN THE COIN CELL VOLTAGE WAS OBSERVED AFTER THIS STRESS TESTING. FURTHERMORE, THE PAD CLOCK INCREMENTED THROUGHOUT THIS TIME AND NOT DESYNCHRONIZE. THIS CONFIRMED THE FAILURE OF Q43 HAD RESULTED IN THE OBSERVED FAULTS. INFORMATION FROM THE HISTORY LOG SHOWED THAT THE FIRST RTC TICK TEST FAILURE OCCURRED AFTER THE (B)(6) 2019, THEREFORE IT IS ASSUMED THAT THE COIN CELL HAD INITIALLY FAILED AFTER THIS DATE. HOWEVER, THE DEVICE THEN PROCEEDED TO PASS TWO SELF-TESTS BEFORE FAILING THE REMAINING SELF-TESTS. THIS WOULD SUGGEST THAT DURING THE INITIAL FAILURE, THE COIN CELL VOLTAGE WAS STILL ON THE BOUNDARY OF FUNCTIONING, BEFORE FAILING ENTIRELY AFTER THE (B)(6) 2019. AN RTC FAILURE IS NOT A CRITICAL FAILURE AND DOES NOT AFFECT THE DEVICE¿S ABILITY TO DELIVER THERAPY AS DEMONSTRATED DURING THE INVESTIGATION. 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 A NEW SAM 350P.

    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

    NO GREEN STATUS INDICATOR FLASHING AND BEEP. DEVICE SERVICE REQUIRED PROMPT WHEN SWITCHED ON. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    NO GREEN STATUS INDICATOR FLASHING AND BEEP. DEVICE SERVICE REQUIRED PROMPT WHEN SWITCHED ON. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407696 PACKAGE,350P,PP03,DE,350-BAS-DE-10 M727SAM350P MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1