BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C230 COMPRESSOR

    MDR report key: 2894438 · Received December 27, 2012

    Report

    Report Number
    2023050-2012-00366
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 10, 2012
    Manufacturer
    EKOM SPOL. SR. O
    Product Code
    BTI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PATIENT INFO WAS NOT PROVIDED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING PATIENT USE, WHILE SETTING A PATIENT UP ON AN E360 VENTILATOR WITH A C230 COMPRESSOR, THE COMPRESSOR WOULD NOT TURN ON. THE PATIENT WAS MANUALLY VENTILATED FOR 10 MINUTES BEFORE BEING TRANSFERRED TO ANOTHER COMPRESSOR. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C230 COMPRESSOR BTI EKOM SPOL. SR. O C230

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention