BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENLON SIGMA DELTA

    MDR report key: 9865004 · Received March 23, 2020

    Report

    Report Number
    9865004
    Event Type
    Malfunction
    Date Received
    March 23, 2020
    Date of Event
    February 21, 2020
    Report Date
    March 4, 2020
    Manufacturer
    DRE, INC DBA AVANTE HEALTH SOLUTIONS
    Product Code
    CAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT IN OPERATION ROOM FOR CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. WHILE ON BYPASS, PERFUSION NOTICED THAT HER ISOFLURANE WAS LEAKING FROM HER MACHINE. NURSE MANAGER MADE AWARE. THE OPERATION ROOM TEAM MADE AWARE. SOME MEMBERS OF THE TEAM FELT EFFECTS OF GAS (EX. DIZZY, LIGHTHEADED) AND HAD TO LEAVE ROOM FOR PERIODS OF TIME, MANAGER AWARE. GAS WAS TURNED OFF BY PERFUSION, AS SOON AS WAS POSSIBLE. PROCEDURE FINISHED WITHOUT INCIDENT TO THE PATIENT. MANUFACTURER RESPONSE FOR ANETHESIA UNIT VAPO, DRE SIGMA DELTA (PER SITE REPORTER). THEY RECOMMENDED SENDING UNIT BACK. IT WAS CALIBRATED IN (B)(6) 2019 SO THE ASSESSMENT/REPAIR MAY FALL UNDER WARRANTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333668 PENLON SIGMA DELTA VAPORIZER, ANESTHESIA, NON-HEATED CAD DRE, INC DBA AVANTE HEALTH SOLUTIONS SIGMA DELTA

    Patients

    Seq Age Sex Outcome Treatment
    1 27740 DA