BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIASYS

    MDR report key: 1624129 · Received March 2, 2010

    Report

    Report Number
    2021710-2010-00005
    Event Type
    Death
    Date Received
    March 2, 2010
    Date of Event
    February 2, 2010
    Report Date
    March 2, 2010
    Manufacturer
    CARFUSION
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) - THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. "APPARENTLY THIS VENTILATOR BELONGS TO (B) (4) AND IS ONE OF THEIR RENTALS. SO WHEN THIS HAPPENED IT WAS RETURNED TO (B) (4) AND IT WAS CHECKED BY THEM AND THEY SAID THE UNIT IS WORKING PROPERLY." A LETTER WAS SENT TO (B) (4) VIA FAX REQUESTING A COPY OF THEIR EVALUATION. AS OF THE DATE OF THIS REPORT, THERE HAS BEEN NO RESPONSE. BASED ON THE INFORMATION THAT CAREFUSION HAS AT THIS POINT, CAREFUSION HAS DETERMINED THAT THERE WAS NO FAILURE OF THE UNIT TO PERFORM AS INTENDED AND AS SUCH DID NOT CAUSE NOR CONTRIBUTED TO THE DEATH OF THE PATIENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. "A DEATH OCCURRED WHILE THE PATIENT WAS ON THIS VENTILATOR. THE RISK MANAGER IN THE FACILITY IS SURE IT WAS NOT THE VENTILATOR'S FAULT, THEY ARE ATTRIBUTING THIS TO OPERATOR ERROR. ACCORDING TO [NAME REMOVED] THIS WAS NOT REPORTED TO FDA. HER CONTACT INFO IS LISTED BELOW." "[CONTACT INFORMATION REMOVED]". "SHE CALLED TO TALK TO [NAME REMOVED] AS [NAME REMOVED] GAVE HER HIS NAME. APPARENTLY THIS VENTILATOR BELONGS TO (B) (4) AND IS ONE OF THEIR RENTALS. SO WHEN THIS HAPPENED IT WAS RETURNED TO (B) (4) AND IT WAS CHECKED BY THEM AND THEY SAID THE UNIT IS WORKING PROPERLY." "[NAME REMOVED] HAD A PRINT OUT OF THE EVENT LOG AND FROM THE HOURS OF 5490 TO 5517 THE UNIT HAD MULTIPLE XDCR FAULT ERRORS." "THE VENTILATOR APPARENTLY HAD BECOME DISCONNECTED FROM THE INSP LIMB AT THE HUMIDIFIER FOR 18 MINUTES." "[NAME REMOVED] ASKED WHAT THE DIFFERENCES BETWEEN THE XDCR FAULT AND THE CIRCUIT DISCONNECT WAS. SHE DID NOT HAVE THE VENTILATOR ON HAND TO CHECK SOME OTHER CODES, SO WE WERE UNABLE TO LOOK AND SEE WHAT THE CODES WERE. SHE WAS ADAMANT THAT THIS WAS USER ERROR AND THEY FELT THE UNIT WAS WORKING WELL AND ALARMING BUT THAT THE STAFF OR WHO EVER WAS IN THE ROOM KEPT PRESSING THE ALARM SILENCE CONTINUALLY." ON FEBRUARY 3, 2010, CAREFUSION SENT A LETTER VIA E-MAIL TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT TO INCLUDE INFORMATION PERTAINING TO THE PRIMARY AND SECONDARY CAUSES OF DEATH. AS OF THE DATE OF THIS REPORT THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASYS CBK VENTILATOR, CONTINOUS, FACILITY USE CBK CARFUSION VELA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death