BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIASYS

    MDR report key: 1023229 · Received March 28, 2008

    Report

    Report Number
    2021710-2008-00024
    Event Type
    Death
    Date Received
    March 28, 2008
    Date of Event
    February 19, 2008
    Report Date
    March 28, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CARDINAL HEALTH HAS REQUESTED THAT THE USER FACILITY RETURN THE ALLEGED FAULTY PT CIRCUIT SUPPORT ARM TO THE MFR FOR EVALUATION. AS OF THE DATE OF THIS REPORT, THE ALLEGED FAULTY PT CIRCUIT SUPPORT ARM HAS NOT BEEN REC'D BY THE MFR.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION CONCERNING THE EVENT AND THE CONDITION OF THE PT WAS DOCUMENTED BY A CARDINAL HEALTH TECHNICAL SUPPORT REP. IN RESPONSE TO PHONE CONVERSATIONS WITH A CARDINAL HEALTH FIELD SERVICE REPRESENTATIVE AND A USER FACILITY REP. "FIELD SERVICE REP [NAME REMOVED] CALLED IN TO INFORM ME THAT HE HAD REC'D A CALL FROM A CUSTOMER, THAT STATED THAT A PT THAT WAS ON OUR VENT DIED AS A RESULT OF CIRCUIT ARM MALFUNCTION. CUSTOMER ACCORDING TO [NAME REMOVED] WAS WITH HOLDING INFO CONCERNING THE INCIDENT. [NAME REMOVED] DID TELL CUSTOMER THAT THEY NEED TO CALL TECH SUPPORT AND REPORT INCIDENT. I CALLED CUSTOMER AND LEFT A MESSAGE REQUESTING S/N AND TIME OF INCIDENT. I WILL FOLLOW UP WITH CUSTOMER A SECOND TIME. "I CALLED CUSTOMER A THIRD TIME AND WAS SUCCESSFUL IN GETTING A HOLD OF [USER FACILITY REPRESENTIVE]. CUSTOMER STATES, THAT THE WIFE OF THE PT NOTICED THAT SOMETHING WAS NOT RIGHT WITH PT, SO SHE IMMEDIATELY WENT TO GET NURSE. WHEN NURSE ENTERED THE ROOM, SHE NOTICED THAT THE PT WAS EXTUBATED. THE PT WAS IN A BERIATRIC BED THAT ROTATES FROM SIDE TO SIDE WHEN INCIDENT OCCURRED. ACCORDING TO CUSTOMER, THE PT CIRCUIT ARM WAS BELOW THE LEVEL OF THE BED WHEN NURSE WALKED IN. ACCORDING TO CUSTOMER, AS A RESULT OF THE PT BEING EXTUBATED, IN WHICH EXTUBATION WAS DISCOVERED AT 4:50 PM IN 2008, PATIENT DIED AT 5:28 PM THE SAME DAY. ACCORDING TO CUSTOMER, INVESTIGATION OF INCIDENT THE CIRCUIT ARM WAS UNABLE TO SUSTAIN WEIGHT AND HOLD PROPER POSITION EVEN WITH PROPER USE OF CIRCUIT ARM." THE FOLLOWING ADDITIONAL INFO CONCERNING THE EVENT WAS COPIED FROM A LETTER FROM THE USER FAICLITY THAT WAS IN REPSONSE TO A LETTER SEND BY CARDINAL HEALTH SEEKING ADDITIONAL INFO. " INADVERTENT EXTUBATION. SUPPORT ARM ON VENTILATOR FOUND BELOW LEVEL OF BED. VENTILATOR DID ALARM [PATIENT] EXPIRED IN 2008 - BILATERAL PULMONARY EMBOLI DUE TO DEEP VEIN THROMBOSIS."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death "RENTAL"| HILL ROOM I123 TOTAL CARE BARIATRIC PLUS BED.