BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,350P,PP01,EN,350-BAS-US-10

    MDR report key: 7901162 · Received September 24, 2018

    Report

    Report Number
    3004123209-2018-00585
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Date of Event
    September 1, 2018
    Report Date
    July 30, 2019
    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

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

    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 12TH JUNE 2014. HEAVY CORROSION ON MULTIPLE CRITICAL CIRCUITS ON THE PCBA HAD RESULTED IN THE REPORTED FAULT OF NOT SWITCHING ON AND NO STATUS INDICATOR. THE HEAVY CORROSION ON THE PCBA AND THE EVIDENCE OF MOISTURE MARKS ON THE UPPER CASE ASSEMBLY WOULD INDICATE THAT THE DEVICE HAD BEEN STORED IN THE PRESENCE OF MOISTURE. ADDITIONALLY, THE LOW TEMPERATURES RECORDED IN THE HISTORY LOG WOULD INDICATE THE DEVICE WAS STORED OUTSIDE THE RECOMMENDED STAND-BY TEMPERATURE OF 0°C WITH A LOW OF -10.6°C RECORDED. THE INVESTIGATION IS UNABLE TO DETERMINE WHEN THE SCREWS WHERE REMOVED, HOWEVER, IF THE SCREWS HAD BEEN REMOVED WHEN THE DEVICE WAS IN PRESENCE OF MOISTURE OF MOISTURE THIS WOULD HAVE AIDED THE MOISTURE INGRESS. THE DEVICE SUCCESSFULLY PASSED THE FINAL UNIT TEST (H032-014-004) ON THE 12TH JUNE 2014. DURING THIS TESTING THE SCREWS WOULD HAVE BEEN INSPECTED AND THEREFORE INDICATES THAT THE SCREWS WERE REMOVED AFTER DISPATCH FROM HEARTSINE. THE USER SHOULD BE ADVISED OF THE RECOMMENDED STORAGE CONDITIONS AS DETAILED WITHIN THE USER MANUAL AS BEING LOCATED IN A CLEAN, DRY ENVIRONMENT AT A TEMPERATURE BETWEEN 0 TO 50°C AND 5 TO 95% RELATIVE HUMIDITY (NON-CONDENSING). 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

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WAS NO STATUS INDICATOR FLASHING.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WAS NO STATUS INDICATOR FLASHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744922 PACKAGE,350P,PP01,EN,350-BAS-US-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1