BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV1000

    MDR report key: 8356374 · Received February 20, 2019

    Report

    Report Number
    2015691-2019-00559
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    January 28, 2019
    Report Date
    January 29, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K131892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS FURTHER EVALUATED BY EDWARDS ENGINEERS. THERE WAS NO PHYSICAL DAMAGE RELATED TO FIRE, BUT THERE WAS BURN OR SPARK RESIDUE VISIBLE ON THE UNIT. THE FUSES ON THE AC INPUT F100 AND F101 WERE BLOWN. NO AC POWER COULD GO INTO THE POWER SUPPLY. THE DIODE D102 TERMINALS WERE SHORTED. THE Q100 DRAIN AND SOURCE WERE SHORTED. THESE FAILURES INDICATE THAT SOME SORT OF A LARGE CURRENT SURGE OCCURRED OVER THE POWER SUPPLY LIMITS. THE PUMP UNIT DAMAGE, ESPECIALLY THE CRACK AND THE MISSING HARDWARE, INDICATES THAT THE UNIT WAS EITHER DROPPED OR TAMPERED WITH.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    OUR PRODUCT EVALUATION LABORATORY RECEIVED THE EV1000 NI UPGRADE SYSTEM. THE PUMP UNIT WAS CONNECTED TO POWER AND IT DID NOT START WORKING. THERE WERE NO MELTED PARTS OBSERVED ON THE PUMP UNIT OR POWER ADAPTOR DURING THE VISUAL INSPECTION. THE DEVICE WAS SENT TO THE MANUFACTURER FOR FURTHER EVALUATION. THE DATABOX AND PANEL POWERED UP WITH NO ERRORS AND NO BURN RESIDUE WAS FOUND. THE PANEL POWERED UP TO CLEARSIGHT MODE. IT WAS ABLE TO SWITCH IT TO THE DATABOX WITH NO ERRORS. THE DATABOX PASSED THE FUNCTIONAL TESTING. WHEN THE EVPMP WAS ATTACHED TO AC POWER IT DID NOT TURN ON. A HOLE WAS BLOCKED BY THE LED FLAT CABLE, WHICH WAS DAMAGED. THE DEVICE POWERED UP WITH A KNOWN WORKING POWER SUPPLY. THERE WAS NO EVIDENCE OF SPARKS, SMOKE, OR FIRE ON THE POWER SUPPLY OR THE POWER INLET. THE REAR HOUSING DID HAVE CRACKS NEAR THE POWER SUPPLY'S POWER ENTRY MODULE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO RELATED NON-CONFORMANCES WERE FOUND. AN ENGINEERING EVALUATION HAS BEEN INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. A COMPLAINT OF SPARKS COULD RESULT IN A FIRE. FIRES HAVE THE POTENTIAL TO INJURE A PATIENT OR THE USER. IN THIS INSTANCE THERE WAS NO HARM TO A PATIENT OR USER AND THE CUSTOMER COMPLAINT OF SPARKING WAS UNABLE TO BE CONFIRMED BY EVALUATION. THERE WAS NO INDICATION OR EVIDENCE OF A MANUFACTURING DEFECT. 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 HAS BEEN RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT YET BEEN EVALUATED. UPON COMPLETION OF THE EVALUATION 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.

    Description of Event or Problem · 1

    AS REPORTED BEFORE USE WITH A PATIENT, THE MONITOR OF AN EV1000 NI FULL PLATFORM, SUDDENLY TURNED OFF AFTER A SPARK OCCURRED. IT WAS NOT SPECIFIED FROM WHICH PART OF THE SYSTEM THE SPARK CAME FROM. THE POWER CABLE WAS CHECKED AND SEEMED TO BE OKAY. THERE WAS NO FIRE OR SMOKE; ONLY SPARKS. THERE WAS NO CONSEQUENCE FOR THE PERSONNEL OR PATIENT. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE PLATFORM WAS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149815 EV1000 COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION DXG EDWARDS LIFESCIENCES EV1000NI

    Patients

    Seq Age Sex Outcome Treatment
    1