BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV1000

    MDR report key: 8191040 · Received December 21, 2018

    Report

    Report Number
    2015691-2018-05532
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    December 6, 2018
    Report Date
    December 6, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K131892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT YET BEEN RECEIVED. UPON THE RETURN OF THE PRODUCT A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS AS WELL AS THE DEVICE HISTORY RECORD. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

    Additional Manufacturer Narrative · 1

    THE AWARE DATE WAS CORRECTED TO 2/8/2019, TO REFLECT THE DHR REVIEW DATE.

    Additional Manufacturer Narrative · 1

    THE EV1000 PLATFORM SYSTEM WAS RETURNED FOR PRODUCT EVALUATION. THERE WAS NO DEFECT FOUND DURING THE VISUAL INSPECTION OF THE DATABOX, POWER CORD, AND POWER ADAPTER. THERE WERE NO BURN SIGNALS OR ANY OTHER DAMAGE FOUND. THERE WERE NO FUNCTIONAL DEFECTS FOUND. THE DATABOX PASSED ALL FUNCTIONAL TESTS WITHOUT ANY ISSUES. THE DEVICE SERVICE HISTORY RECORD REVIEW WAS COMPLETED AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON-CONFORMANCES. THERE WAS NO PREVIOUS SERVICING OF THIS UNIT. THE REPORTED EVENT WAS NOT CONFIRMED BY THE EVALUATION. THERE IS NO EVIDENCE OR INDICATION THAT A MANUFACTURING DEFECT IS RESPONSIBLE FOR THE REPORTED ISSUE; THEREFORE NO CORRECTIVE ACTION WAS TAKEN. A COMPLAINT OF SMOKE COULD RESULT IN A FIRE. IN THIS INSTANCE, THERE WAS NO HARM TO A PATIENT OR USER AND THE CUSTOMER COMPLAINT OF SMOKING WAS UNABLE TO BE CONFIRMED BY EVALUATION. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

    Description of Event or Problem · 1

    AS REPORTED, DURING THE SET-UP AND BEFORE USE WITH PATIENT, THIS EV1000 DATABOX HAD A POWER SHOCK WITH STRONG SMELL AND SMOKE. IT HAPPENED AT THE CONNECTION POINT OF THE POWER CORD WITH THE DATABOX. NO SPARKS OR FIRE WAS OBSERVED. THERE NO CONSEQUENCE FOR THE PATIENT AND THE MEDICAL STAFF. THE DEVICE WAS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028816 EV1000 COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION DXG EDWARDS LIFESCIENCES EV1000A

    Patients

    Seq Age Sex Outcome Treatment
    1