BEUDAMED
    FDA Adverse Event Injury Summary report: N

    731 SERIES PORTABLE VENTILATOR MODEL EMV+

    MDR report key: 2809528 · Received October 22, 2012

    Report

    Report Number
    2242630-2012-00053
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    April 18, 2012
    Report Date
    October 19, 2012
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    CBK
    PMA / PMN Number
    K091238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PROBLEM FOUND WITH DEVICE AUTO CAL VALVE BEING OUT OF RANGE. VALVE WAS REPLACED.

    Description of Event or Problem · 1

    IMPACT 731/EMV+ VENTILATOR WAS BEING USED ON A PT WHEN IT SHOWED A RUN TIME ERROR CODE AND BECAME INTERMITTENTLY OPERABLE. THERE WAS NO SERIOUS INJURY TO THE PT REPORTED BY THE END USER. THE END USER REPORTED THAT BACK UP VENTILATION EQUIPMENT WAS AVAILABLE AT THE TIME OF THE EVENT BUT DID NOT REPORT THAT IT WAS USED. THOUGH SERIOUS INJURY TO THE PT WAS NOT REPORTED, WE HAVE SUBMITTED THIS AS A SERIOUS INJURY BECAUSE IT IS POSSIBLE THAT INTERVENTION USING BACK-UP VENTILATION EQUIPMENT MAY HAVE BEEN NEEDED TO PRECLUDE PERMANENT IMPAIRMENT OR DAMAGE DUE TO THE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 731 SERIES PORTABLE VENTILATOR MODEL EMV+ VENTILATOR CBK IMPACT INSTRUMENTATION, INC. 731/EMV+ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE REPORTED BY THE OPERATOR