BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NORKOMED 3

    MDR report key: 274255 · Received April 18, 2000

    Report

    Report Number
    MW1018696
    Event Type
    Injury
    Date Received
    April 18, 2000
    Date of Event
    April 5, 2000
    Report Date
    April 13, 2000
    Manufacturer
    DRAGER, INC.
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    OR PHYSICIANS WERE PREPARING TO TAKE PT OFF "BYPASS" FOLLOWING CABG PROCEDURE. WHEN THE NARKOMED 3 ANESTHESIA UNIT WAS TURNED ON TO SWITCH THE PT OVER THE UNIT WOULD NOT FUNCTION PROPERLY. ANOTHER ANESTHESIA UNIT WAS BROUGHT IN TO REPLACE IT. THE PT'S CONDITION WAS NOT COMPROMISED BECAUSE THEY WERE UNDER DIRECT SUPERVISION OF THE ATTENDING PHYSICIANS. THE MFR WAS NOTIFIED OF THE MALFUNCTION, AND IT WAS FOUND THAT THE VENTILATOR SOLENOID SWITCH WAS THE CAUSE OF THE VENTILATOR STICKING IN THE INSPIRATORY PHASE. THE UNIT HAD UNDERGONE VIGILANCE PREVENTIVE MAINTENANCE BY THE MFR THE MONTH BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORKOMED 3 ANESTHESIA UNIT BSZ DRAGER, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention