BEUDAMED
    FDA Adverse Event Other Summary report: N

    VIASYS

    MDR report key: 1278328 · Received December 23, 2008

    Report

    Report Number
    2021710-2008-00113
    Event Type
    Other
    Date Received
    December 23, 2008
    Date of Event
    November 23, 2008
    Report Date
    December 23, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARDINAL HEALTH POST MARKET QUALITY ASSURANCE DEPT. SENT A LETTER TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT AND THE STATUS OF THE PATIENT. AS OF THE DATE OF THIS REPORT, THE USER FACILITY HAS NOT RESPONDED TO THAT LETTER. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURE. EVENT CODES WERE DERIVED BASED ON INFORMATION DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION BETWEEN CARDINAL HEALTH CLINICAL SPECIALIST AND USER FACILITY CLINICIAN. THE FOLLOWING INFO IS A SUMMARY OF THE EVAL PERFORMED BY THE CARDINAL HEALTH FIELD SERVICE REP. AND THE INVESTIGATION PERFORMED BY CARDINAL CLINICAL SPECIALIST IN CONJUNCTION WITH THE USER FACILITY CLINICIAN. THE CARDINAL HEALTH FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND WAS NOT ABLE TO REPRODUCE THE REPORTED FAILURE THUS WAS NOT ABLE TO IDENTIFY A ROOT CAUSE IN THIS ALLEGED EVENT. THE CARDINAL HEALTH FIELD SERVICE ENGINEER RAN THE DEVICE THROUGH A COMPLETE CHECKOUT TO ENSURE IT MEETS ALL FACTORY SPECS. UPON COMPLETION, THE DEVICE RETURNED TO THE CUSTOMER TO BE PLACED BACK INTO SERVICE. THE EVENT WAS INVESTIGATED BY THE CARDINAL HEALTH CLINICAL SPECIALIST IN CONJUNCTION WITH THE USER FACILITY CLINICIAN AND DETERMINED THAT THE FLOW TRIGGER SETTING WAS SET TOO SENSITIVE CAUSING THE DEVICE TO AUTOCYCLE, THE DEVICE'S FLOW TRIGGER SETTING WAS NOT SET APPROPRIATELY FOR THE PATIENT'S CLINICAL CONDITION.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEATH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. "CUSTOMER REPORTED AN INCIDENT ON THIS UNIT, HE CLAIMS THIS VENTILATOR WAS ON A NEONATE PATIENT. PROBLEM REPORTED, UNIT AUTOCYCLES, THE INCIDENT OCCURED IN 2008, SETTINGS: MODE = SIMV, RATE = 25, PIP = 14, PSV = 12, PEEP = 4, FIO2% = 21, FLOW TRIG = 1, AT 14:20 THEY MAD EA CHANGE ON THE SETTINGS: MODE: SPON/CPAP, PSV = 16, PEEP = 4, FIO2% = 21, FLOW TRIG = 1. CUSTOMER CLAIMS THE SPONT. RATE WAS READING 200 BPM. UNIT HAD A HUMIDIFIER IN LINE." AT 16:40, THEY NOTICED THAT THE PATIENT HAD SOME TYPE OF INJURY, VENTILATOR WAS REMOVED FROM PATIENT AND INSTALL SOME KIND OF TEST LUNG OR A BAG, AND THE VENTILATOR AUTOCYCLES. BIOMED HAS THIS UNIT IN HIS SHOP, HE DID NOT TEST THE VENTILATOR AT ALL, HE WANTS A VIASYS SERVICE REP. TO COME OUT AND TEST THIS UNIT. HE ALSO CLAIMS THE PATIENT MAY HAVE BRAIN DAMAGED".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention NEONATAL HEATED WIRE DISPOSABLE CIRCUIT| HUDSON RCI CONCHA HUMIDIFICATION SYSTEM| HOT WIRE FLOW SENSOR| TO 50 PSI O2 AND AIR