BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIASYS

    MDR report key: 1030167 · Received April 12, 2008

    Report

    Report Number
    2021710-2008-00021
    Event Type
    Malfunction
    Date Received
    April 12, 2008
    Date of Event
    February 21, 2008
    Report Date
    April 10, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CARDINAL HEALTH SENT A LETTER TO THE USER FACILITY SEEKING ADD'L INFO CONCERNING THE REPORTED EVENT. AS OF THE DATE OF THIS REPORT, THERE HAS BEEN NO RESPONSE TO THE LETTER FROM THE USER FACILITY. THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECH EVALUATED THE DEVICE AND FOUND THAT THE FOLLOWING PNEUMATICS ASSEMBLIES; GAS DELIVERY ENGINE, COMPRESSOR FILTER, NEBULIZER, BLEED VALVE, AND ACCUMULATOR ARE CONTAMINATED WITH WATER. IT WAS DETERMINED THAT THE ROOT CAUSE OF THE WATER CONTAMINATION WAS THAT THE USER FACILITY'S COMPRESSED AIR SYSTEM HAD EXCESSIVE WATER IN IT. ONCE THE EVAL WAS COMPLETE, THE DEVICE WAS SENT TO THE CARDINAL HEALTH SERVICE DEPT. AND A COST ESTIMATE FOR THE REPAIR OF THE DEVICE WAS SENT TO THE USER FACILITY. AS OF THE DATE OF THIS REPORT, THE USER FACILITY HAS NOT INFORMED THE CARDINAL HEALTH SERVICE DEPT. AS TO WHETHER THEY WANT THE DEVICE REPAIRED OR NOT. PLEASE BE AWARE THAT THERE WERE CONFLICTING REPORTS ASSOCIATED WITH THIS EVENT AS FOLLOWS: IN 2008, A REPORT OF WATER IN THE HOSES THAT CONNECT TO THE ACCUMULATOR INLET/USER FACILITY WANTS TO SEND DEVICE IN FOR REPAIR. USER FACILITY BIOMED STATED DEVICE WAS NOT ON A PT. THE SAME DAY, CARDINAL HEALTH ISSUED A SERVICE CALL NUMBER TO THE USER FACILITY TO RETURN THE DEVICE FOR EVAL AND REPAIR. ON 03/03/08, USER FACILITY BIOMED REQUESTED THAT A FIELD SERVICE REP COME TO CHECK OUT THE DEVICE AND REPORTED THAT THE DEVICE WAS ON A PT AND THE PT DIED. THE USER FACILITY BIOMED ALSO CLAIMS THEY WERE NOT NOTIFIED OF THE PT DEATH PRIOR TO THEIR INITIAL CALL TO CARDINAL HEALTH ON ORIGINAL DATE. THE FOLLOWING MONTH, FIELD SERVICE REP CALLED USER FACILITY TO SET UP AN APPOINTMENT FOR 1:00 PM. ON THE SAME DAY, CARDINAL HEALTH SALES REP SPOKE WITH THE RT DIRECTOR, WHO REPORTED THAT THERE WAS NOT A PT DEATH ASSOCIATED WITH WATER GETTING INTO THIS DEVICE, AND THAT WHEN THE STAFF NOTICED THE WATER, THE DEVICE WAS REMOVED AND THE PT WAS PLACED ON ANOTHER DEVICE.

    Description of Event or Problem · 1

    THE FOLLOWING INFO CONCERNING THE EVENT AND THE CONDITION OF THE PT WAS DOCUMENTED BY CARDINAL HEALTH EMPLOYEES IN RESPONSE TO PHONE CONVERSATIONS WITH A USER FACILITY REPRESENTATIVE AND A CARDINAL HEALTH SALES REPRESENTATIVE. IN 2008, "WATER GOT INSIDE THIS VENTILATOR, BIOMED CLAIMS THERE IS WATER ON THE HOSE THAT CONNECTS TO THE INLET OF THE ACCUMULATOR, INFORMED CUSTOMER THAT THE GDE AND THE ACCUMULATOR MAY HAVE TO BE REPLACED, SHE WANTS TO SEND IT IN FOR REPAIRS, AND HAVE IT CHECK FOR WATER DAMAGED. SHE WANTS AN RMA#, UNIT IS ON A PT, S/W REV. 3.9A, CUSTOMER WANTS A BOX TO SHIP IT IN." THE FOLLOWING MONTH, "CUSTOMER CALL BACK TODAY, REGARDING THIS UNIT, THE HOSPITAL WANTS FIELD SERVICE TO COME OUT AND CHECK THIS UNIT OUT, WATER GOT INTO THIS VENTILATOR, UNIT WAS GOING TO COME TO PALM SPRINGS FOR EVAL AND REPAIRS BECAUSE OF THE WATER DAMAGE. I WAS ALSO INFORMED TODAY, THAT THIS UNIT WAS ON A PT AND THERE WAS AN INCIDENT AND THE PT DIED. WHEN THE ORIGINAL PROBLEM WAS REPORTED, BIOMED CLAIMS SHE WAS NOT INFORMED OF THE INCIDENT. INFORMED CUSTOMER THAT FIELD SERVICE MAY NOT HAVE THE EQUIPMENT TO DETERMINE HOW FAR THE WATER GOT INTO THE VENTILATOR AND FIELD SERVICE MANAGEMENT MAY RECOMMEND TO BRING THIS UNIT TO OUR SERVICE DEPT." THE FOLLOWING INFO CONCERNING THE EVENT AND THE CONDITION OF THE PT WAS DOCUMENTED BY CARDINAL HEALTH EMPLOYEES IN RESPONSE TO PHONE CONVERSATIONS WITH A USER FACILITY REPRESENTATIVES AND A CARDINAL HEALTH SALES REPRESENTATIVE. THE SAME DAY, "THIS VENT FAILED ON A PT AND THE PT DIED AS A RESULT OF THE FAILURE ON THE VENT. THE BIOMED STATES THE VENT FAILED BECAUSE WATER GOT INSIDE THE VENT FROM THE AIR INLET. CUSTOMER WANT US TO LOOK AT VENT BEFORE SENDING VENT TO FACTORY. WE WILL ONLY LOOK AT THE VENT FROM A VISUAL STANDPOINT, CHECKING THE AIR INLET FILTER FOR WATER, FIELD SERVICE RECOMMENDS THAT WE DO NOT DISASSEMBLE THE VENT DUE TO THE HIGHLY VOLATILE SITUATION. WE RECOMMEND SENDING BACK TO FA LAP ASAP. VENT BOX IS SUPPOSED TO BE HERE TODAY AFTER LUNCH. WE WILL OBTAIN A CR # AND SEND BACK TO FACTORY OVERNIGHT." THE SAME DAY, "OUR SALES REP. [NAME REMOVED] GAVE US AN UPDATE REGARDING THIS VENTILATOR, HE GOT IN CONTACT WITH THE RT DIRECTOR REGARDING THE PT THAT DIED, HE WAS INFORMED BY THE DIRECTOR [NAME REMOVED] THAT THE PT DID NOT DIE BECAUSE WATER GOT IN THIS VENTILATOR, WHEN THE STAFF NOTICED THE WATER, THE VENTILATOR WAS REMOVED AND THE PT PLACED ON ANOTHER VENTILATOR, THEREFORE, THE PT DID NOT DIE BECAUSE OF THE VENTILATOR, UNIT IS COMING BACK FOR REPAIRS AS ORIGINAL PLAN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASYS VOLUME VENTILATOR CBK CARDINAL HEALTH 207, INC. AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK