BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 360P AND PAD-PAK

    MDR report key: 7676675 · Received July 11, 2018

    Report

    Report Number
    3004123209-2018-00449
    Event Type
    Malfunction
    Date Received
    July 11, 2018
    Date of Event
    July 4, 2018
    Report Date
    September 24, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM350P
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 360P 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 360P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE (B)(6) 2017. 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 POWER ON. 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 (B)(6) 2017, 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 SAM 360P.

    Additional Manufacturer Narrative · 0

    INCORRECT SERIAL NUMBER GIVEN BY DISTRIBUTOR. THE CORRECT SERIAL NUMBER IS (B)(4).THE DEVICE TYPE IS SAM 360P.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. DEVICE LED ICONS WONT LIGHT UP.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. DEVICE LED ICONS WONT LIGHT UP.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. DEVICE LED ICONS WONT LIGHT UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519130 HEARTSINE SAMARITAN 360P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1