BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIASYS

    MDR report key: 868987 · Received June 22, 2007

    Report

    Report Number
    2021710-2007-00038
    Event Type
    Injury
    Date Received
    June 22, 2007
    Date of Event
    May 25, 2007
    Report Date
    June 22, 2007
    Manufacturer
    VIASYS RESPIRATORY CARE INC
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED BY A VIASYS TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. A LETTER WAS SENT TO THE USER FACILITY REQUESTING ADD'L INFO CONCERNING THE REPORTED EVENT AND THE CONDITION OF THE PT. AS OF THE DATE OF THIS REPORT IN 2007, THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A VIASYS TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP: "THE RESPIRATORY COORDINATOR CALLED TO INFORM THAT TWO UNITS WERE NOT DELIVERING THE SET FLO2 100%. PER RESPIRATORY COORDINATOR THEIR WAS NO CORRESPONDING ALARM LOW FLO2 ALARM PER RESPIRATORY COORDINATOR THE UNIT MONITORED FLO2 WAS READING 21% PER PTS LOW O2 SATURATIONS/PAO2 READINGS THE UNIT WAS CHANGED PTS SATURATIONS IMPROVED PT IS TILL ON A VENT UNTIL THE CUSTOMER IS EXTREMELY CONCERNED THEY ARE IN THE PROCESS OF DOING MEDWATCH ALERT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASYS VOLUME VENTILATOR CBK VIASYS RESPIRATORY CARE INC AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Life Threatening| R