BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIASYS

    MDR report key: 1318344 · Received December 3, 2008

    Report

    Report Number
    2021710-2008-00102
    Event Type
    Malfunction
    Date Received
    December 3, 2008
    Date of Event
    October 1, 2008
    Report Date
    December 2, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH THE USER FACILITY INDICATED ON THEIR MAUDE EVENT REPORT THAT THE DEVICE IS AVAILABLE FOR EVAL, THE USER FACILITY HAS NOT RESPONDED TO CARDINAL HEALTH REQUEST FOR THE UNIT TO BE RETURNED FOR EVAL. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO PROVIDED BY THE USER FACILITY MAUDE EVENT REPORT RECEIVED FROM THE FDA. CARDINAL HEALTH HAS CONTACTED THE USER FACILITY MULTIPLE TIMES BY PHONE AND BY MAIL IN ORDER TO GET ADD'L INFO CONCERNING THE REPORTED EVENT AND THE CONDITION OF THE PT. AS OF THE DATE OF THIS REPORT, THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. DUE TO THE LACK OF MATERIAL INFO AND END USER RESPONSE, THIS FILE WILL BE CLOSED AND MAY BE REOPENED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE USER FACILITY MAUDE EVENT REPORT RECEIVED BY CARDINAL HEALTH FROM THE FDA ON (B)(6) 2008. "VENTILATOR TOUCH SCREEN LOCKED. PT ABLE TO GET BREATHS BUT NO CHANGES COULD BE MADE TO THE VENTILATOR." THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST FROM THE USER FACILITY MAUDE EVENT REPORT RECEIVED BY CARDINAL HEALTH FROM THE FDA ON (B)(6) 2008. "PER MAUDE EVENT REPORT EVENT DATE (B)(6) 2008 PER CUSTOMER, VENTILATOR TOUCH SCREEN LOCKED. PT ABLE TO GET BREATHS BUT NO CHANGE COULD BE MADE TO THE VENTILATOR." THE FOLLOWING EVENT WAS DOCUMENTED BY CARDINAL HEALTH TECH SUPPORT SPECIALIST AFTER AN ATTEMPT WAS MADE TO CONTACT THE USER FACILITY. "I CALLED THE CUSTOMER REQUESTING UPDATE ON S/N COPY OF ANY EVAL DONE AND IF POSSIBLE, IF WE COULD EVALUATE THE UNIT IN OUR FA LAB. I RECEIVED VOICEMAIL, LEFT DETAIL MESSAGE WITH REFERENCE CALL #."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASYS 73CBK, VENTILATOR CONTINUOUS (RESPIRATOR) CBK CARDINAL HEALTH 207, INC. VELA *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN