BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAMED IVENT

    MDR report key: 2171313 · Received July 15, 2011

    Report

    Report Number
    MW5021405
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 13, 2011
    Manufacturer
    VERSAMED MED. SYSTEMS
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE TRANSFERRING THE PT FROM (B)(6) HOSPITAL ICU TO (B)(6) HOSP ICU (HIGHER LEVEL OF CARE) VERSAMED IVENT (S/N (B)(4)) BEGAN TO MALFUNCTION. THE VENT PASSED A SELF-TEST AS WELL AS OVT TEST PRIOR TO BEING APPLIED TO THE PT. APPROX 15 MIN INTO THE TRANSPORT THE VENT BEGAN TO MALFUNCTION AND WOULD NOT DELIVER TIDAL VOLUME TO THE PT, EVEN USE OF THE MANUAL BREATH CONTROL WOULD NOT DELIVER THE REQUIRED VOLUME. THE PT WAS IMMEDIATELY VENTILATED WITH BVM AND SUPP O2 UNTIL SWITCHED TO A BACK UP VENTILATOR FOR THE REMAINDER OF THE TRANSPORT. DATES OF USE: (B)(6) 2011 - 1646-1700HRS. REASON FOR USE: S/P CARDIAC ARREST. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAMED IVENT IVENT CBK VERSAMED MED. SYSTEMS IVENT 201

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R