BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OB CO#1310451,PKG,350P,PP01,EN,350-BAS-US-10

    MDR report key: 9823365 · Received March 12, 2020

    Report

    Report Number
    3004123209-2020-00065
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    March 2, 2020
    Report Date
    May 30, 2020
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM350P
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 350P DEVICE 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) 2016. THE PAD-PAK (LOT# J0008 2020-12-01) HISTORY RECORD WAS REVIEWED, WHICH SHOWED THE RETURNED PAD-PAK AS 1 OF 214 MANUFACTURED ON THE (B)(6) 2016, 211 OF WHICH WERE SHIP TO HEARTSINE INC ON THE (B)(6) 2016. ALL PAD-PAKS WERE SUBJECT TO BATTERY VOLTAGE TESTING ON THE (B)(6) 2016, WITH NO RECORDED FAILS. UPON RECEIPT THE RETURNED PAD-PAK WAS FOUND TO BE SIGNIFICANTLY DEPLETED, AS PER THE REPORTED FAULT. THE INVESTIGATION REVEALED THAT EACH CELL IN THE PAD-PAK WAS UNIFORMLY DEPLETED, INDICATING THAT THEY HAD BECOME DEPLETED BY AN EXTERNAL LOAD. NO FAULT OR EXCESS CURRENT DRAIN WAS IDENTIFIED ON THE SAM 350P OR RETURNED PAD-PAK THAT WOULD HAVE RESULTED IN THE DEPLETION OF A PAD-PAK PRIOR TO ITS EXPIRY DATE. THE INTEGRITY OF THE MEMBRANE, LED DRIVE CIRCUITRY AND POGO PINS WERE VERIFIED BY MEASUREMENT DURING THE INVESTIGATION. THE DEVICE WAS STRESSED TESTED AT 50°C 95%RH FOR 5 DAYS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. THE DEVICE RECORDED CONSISTENT VOLTAGES THROUGHOUT THIS STRESS TESTING AND DISPLAYED NO FAULTS. INFORMATION FROM THE HISTORY LOG SHOWED THAT AFTER THE (B)(6) 2017, NO SELF-TESTS WERE PERFORMED FOR APPROXIMATELY 19 MONTHS, WHICH WOULD INDICATE A PAD-PAK HAD NOT BEEN INSTALLED WITHIN THE RETURNED UNIT DURING THIS PERIOD. UPON REINSTALLATION ON THE (B)(6) 2018, A SIGNIFICANT DECREASE IN BATTERY VOLTAGE WAS OBSERVED, WHICH WOULD INDICATE THE PAD-PAK HAD DEPLETED OVER THIS PERIOD. THE DEVICE THEN BEGAN TO FAIL SELF-TESTS DUE TO LOW BATTERY FROM THE (B)(6) 2019. THE DEPLETION OF THE PAD-PAK COULD RELATE TO AN ISSUE WITH THE STORAGE CONDITIONS OF THE PAD-PAK DURING THE ABOVE PERIOD OR COULD HAVE BEEN DUE TO INSTALLATION WITHIN A DIFFERENT DEVICE. HOWEVER, THIS COULD NOT BE CONFIRMED. 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.

    Description of Event or Problem · 0

    SAM350P WITH A DEAD BATTERY. THE EXPIRATION DATE IS 2020-12-01. NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2015058. (B)(4).

    Description of Event or Problem · 1

    SAM350P WITH A DEAD BATTERY. THE EXPIRATION DATE IS 2020-12-01. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287410 OB CO#1310451,PKG,350P,PP01,EN,350-BAS-US-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM 350P M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1