BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV1000

    MDR report key: 8299334 · Received February 1, 2019

    Report

    Report Number
    2015691-2019-00371
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Date of Event
    October 26, 2018
    Report Date
    December 11, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K131892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, IT WAS LATER LEARNED THAT THE PRODUCT WAS DISCARDED AT THE FACILITY. WITHOUT THE RETURN OF THE PRODUCT, IT IS NOT POSSIBLE TO DETERMINE IF DAMAGES OR DEFECTS EXISTED ON THE PRODUCT, NOR CAN A ROOT CAUSE OR ANY POTENTIAL CONTRIBUTING FACTORS BE IDENTIFIED. NO ACTIONS WILL BE TAKEN AT THIS TIME. AN ENGINEERING EVALUATION WAS INITIATED AND COMPLETED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. NO MANUFACTURING NON-CONFORMANCE WAS FOUND AS THE MONITOR WAS NOT RETURNED FOR EVALUATION. IT WAS CONFIRMED BY THE CUSTOMER THAT THE POWER SUPPLY WAS NOT MOUNTED AS THE OPERATOR¿S MANUAL INSTRUCTED. THE CONNECTION WITH THE POWER SUPPLY WAS NOT ORIENTED UPWARDS. SMOKE WAS SEEN BUT NO FIRE RESULTED. IT IS UNKNOWN IF SALINE INGRESS INTO THE POWER SUPPLY WAS THE CAUSE OF THE SMOKE. A COMPLAINT OF SMOKE COULD RESULT IN A FIRE. IN THIS INSTANCE THERE WAS NO FIRE AND NO HARM TO A PATIENT OR USER. 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.

    Description of Event or Problem · 1

    AS REPORTED, DURING A SURGICAL PROCEDURE, THE POWER SUPPLY OF THIS EV1000 SYSTEM WAS PHYSICALLY DAMAGED CAUSED BY THE DROP OF SALINE SOLUTION. THE ANESTHESIOLOGIST HEARD A NOISE RELATED TO AN ELECTRICAL BREAKDOWN AND THEN SMELLED SMOKE. HOWEVER, THIS SMOKE DID NOT RESULT FROM A FIRE. THERE WAS NO CONSEQUENCES FOR THE PATIENT NOR THE CLINICAL STAFF. ANOTHER POWER SUPPLY WAS USED IN ORDER TO REPLACE THE DAMAGED ONE. THE POWER SUPPLY WASN'T MOUNTED AS THE MANUAL SHOWED. THE CONNECTION WITH THE POWER SUPPLY CABLE WASN'T ORIENTED UPWARDS, INCREASING THE CHANCE OF AN ELECTRICAL BREAKDOWN RELATED TO THE DROP OF SALINE SOLUTION. THE CLIENT RECEIVED ALL THE NECESSARY INFORMATION CONCERNING THE CORRECT SETTING OF THE POWER SUPPLY. THE DEVICE WAS AVAILABLE FOR EVALUATION. LATER, ON (B)(6) 2019, IT WAS CONFIRMED THAT THE SMOKE WAS ACTUALLY SEEN BY THE ANESTHESIOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91331 EV1000 COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION DXG EDWARDS LIFESCIENCES EV1000A

    Patients

    Seq Age Sex Outcome Treatment
    1