BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV1000

    MDR report key: 8558056 · Received April 26, 2019

    Report

    Report Number
    2015691-2019-01504
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Date of Event
    March 22, 2019
    Report Date
    March 22, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K131892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    OUR PRODUCT EVALUATION LABORATORY RECEIVED THE EV1000A. WHEN THE DATABOX WAS CONNECTED TO POWER, IT DID NOT BOOT UP AND NO SMOKE WAS OBSERVED. AFTER OPENING THE DATABOX, HOWEVER, THERE WAS A BURNT SMELL FOUND. THE VISUAL INSPECTION WAS PERFORMED ON THE ISO AND CPU BOARD BUT NOTHING WAS FOUND. THE DEVICE WILL BE SENT TO THE MANUFACTURER FOR FURTHER EVALUATION. REPORTS OF SMOKE COULD POSSIBLY LEAD TO FIRE. IN THIS INSTANCE THE USER TRIED TO CHANGE THE POWER SUPPLY FROM THE PUMP UNIT TO THE DATABOX WITH A CABLE FROM ANOTHER COMPLETE SYSTEM (EV1000CS). THE SMOKE WAS OBSERVED AFTER THIS POWER SUPPLY CHANGE OCCURRED. THIS ISSUE OCCURRED BEFORE PATIENT USE AND NO USER INJURY WAS REPORTED. 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 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. 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 PRODUCT WAS RETURNED TO OUR MANUFACTURER FOR FURTHER EVALUATION. THE DEVICE HAD A STRONG BURNT SMELL WHEN IT WAS OPENED. IT SMELLED THE STRONGEST NEAR U24 ON THE ISO BOARD. U24 LOOKED DISCOLORED AROUND THE CRACK THAT IT HAD ON ITS SIDE. IT IS SUSPECTED THAT THE SMOKE CAME OUT OF THIS CRACK. NO OTHER PARTS OF THE BOARD HAVE VISIBLE DAMAGE. THE EV1000A HAD AN EXPIRY DATE OF 03/01/2018 AND IS PAST ITS USEFUL LIFE.

    Description of Event or Problem · 1

    AS REPORTED, BEFORE USE WITH A PATIENT, THE BOARD IN THE DATABOX OF AN EV1000 SYSTEM WAS BURNT. IT WAS CONFIRMED THAT SMOKE CAME OUT OF THE DATABOX WHEN THE ISSUE OCCURRED. THIS WAS REPORTED BY THE BIOMEDICAL ENGINEERS. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE PRODUCT WAS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352026 EV1000 COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION DXG EDWARDS LIFESCIENCES EV1000A

    Patients

    Seq Age Sex Outcome Treatment
    1