BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,500P,PP03,DE,500-BAS-DE-10

    MDR report key: 9132979 · Received September 30, 2019

    Report

    Report Number
    3004123209-2019-00333
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Date of Event
    September 1, 2019
    Report Date
    October 18, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 500P WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 500P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 1ST JUNE 2015. UPON RECEIPT THE INSTRUCTIONAL LEDS WOULD NOT ILLUMINATE, WHICH CONFIRMED THE REPORTED FAULT. VISUAL INSPECTION REVEALED THE MEMBRANE TAIL WAS NOT CORRECTLY ALIGNED WITHIN THE J11 CONNECTOR, WHICH HAD RESULTED IN THE MISALIGNMENT OF THE J11 PINS WITH THE MEMBRANE TAIL TRACKS AND THE SUBSEQUENT FAILURE OF THE INSTRUCTIONAL LEDS TO ILLUMINATE. THE FAULT WAS RESOLVED AFTER CORRECTLY REINSTALLING THE MEMBRANE INTO THE J11 CONNECTOR. HEARTSINE RECORDS INDICATE THE DEVICE HAD PERFORMED TO SPECIFICATION DURING OUT QAT TESTING ON THE 1ST JUNE 2015, INDICATING THAT THE MEMBRANE TAIL HAD MADE SUFFICIENT CONTACT WITH THE J11 PINS AT THIS TIME. 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 500P.

    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

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. WHEN THE DEVICE IS SWITCHED ON THE LED INDICATORS DO NOT LIGHT UP. ONLY THE GREEN STATUS LED FLASHES.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. WHEN THE DEVICE IS SWITCHED ON THE LED INDICATORS DO NOT LIGHT UP. ONLY THE GREEN STATUS LED FLASHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931482 PACKAGE,500P,PP03,DE,500-BAS-DE-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1