BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA

    MDR report key: 479749 · Received August 19, 2003

    Report

    Report Number
    MW1029355
    Event Type
    Injury
    Date Received
    August 19, 2003
    Date of Event
    August 11, 2003
    Report Date
    August 12, 2003
    Manufacturer
    VIA SYS HEALTHCARE
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE CHECKING A PT IN SEMI-PRIVATE ROOM, RT, NOTICED FLASHING VENT INOP ALARM ON OTHER PT'S VENTILATOR, VENT HAD NO AUDIBLE ALARM. GRAPHICS HAD ALL GONE FLAT LINE BUT THERE WERE "EXH." TIDAL VOLUMES AND SPONTANEOUS RATES ON THE READOUT, PT BAGGED WHILE VENTILATOR REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VELA VENTILATOR CBK VIA SYS HEALTHCARE 15866-00 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention