BEUDAMED
    FDA Adverse Event Other Summary report: N

    VIASYS

    MDR report key: 1525525 · Received October 27, 2009

    Report

    Report Number
    2021710-2009-00049
    Event Type
    Other
    Date Received
    October 27, 2009
    Date of Event
    April 29, 2009
    Report Date
    October 27, 2009
    Manufacturer
    CAREFUSION 207, INC
    Product Code
    CBK
    PMA / PMN Number
    K013642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 510K#: K022674, K062093, K073069, K081837. (B)(4): RESULTS - PHYSICAL DAMAGE BY END USER. THE FOLLOWING INFO CONCERNING THE EVAL OF THE FILTERS IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION FAILURE ANALYSIS LAB TECH. THE CUSTOMER HAS REPORTED EIGHT FILTERS ARE AFFECTED ALTHOUGH ONLY 5 (B)(4) AVEA DISPOSABLE EXPIRATORY FILTER WITH WATER TRAPS HAVE BEEN RETURNED TO THE CAREFUSION FAILURE ANALYSIS LABORATORY FOR EVAL. ALL OF THE COMPONENTS RETURNED WERE FROM (B)(6) HOSP IN (B)(6). UPON RECEIPT AND EVAL, OUR FAILURE ANALYSIS LABORATORY WAS ABLE TO CONFIRM PHYSICAL DAMAGE TO THE PT CIRCUIT CONNECTION PORT (MALE FITTING) OF THE DISPOSABLE EXPIRATORY FILTER WITH WATER TRAP. OUR FAILURE ANALYSIS LAB DOCUMENTED THESE COMPONENTS WERE REC'D WITH A HAND WRITTEN NOTE THAT STATED "AVEA WATER TRAP SNAPPED OFF WHEN RN HIT SLIGHTLY W/HIP". IT WAS FURTHER IDENTIFIED THAT ANOTHER OF THE RETURNED FILTERS WAS "RAN INTO AN ELEVATOR DOOR RESULTING IN PHYSICAL DAMAGE". THEREFORE BASED ON THE MATERIALS RETURNED AND THE INFO PROVIDED BY THE END USER WE HAVE CONCLUDED THE ROOT CAUSE IN THIS EVENT TO BE MISUSE RESULTING IN PHYSICAL DAMAGE.

    Description of Event or Problem · 1

    (B)(4). "EVENT DESC: THE ISSUE IS WITH THE AVEA DISPOSABLE WATER TRAP WHICH IS A DISPOSABLE VENTILATOR WATER TRAP TO BE USED WITH THE AVEA VENTILATOR. ON EIGHT KNOWN OCCASIONS, THE WATER TRAP EASILY FRACTURED (BROKE) OFF AT THE CONNECTOR SITE FOR THE EXPIRATORY HOSE. IN ALL CASES, THIS DISABLED THE VENTILATOR FROM DELIVERING AIR, AND PTS HAD TO BE MANUALLY VENTILATED UNTIL REPLACED, PUTTING PTS AT POTENTIAL RISK. IN SEVERAL INSTANCES, A CLINICIAN JUST 'BUMPED INTO IT" AND IN OTHER INSTANCES THE CLINICIAN WAS CONNECTING THE VENT CIRCUIT WHEN THE SAID PIECE EASILY FRACTURED." SEE SCANNED PAGE. "DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)". "OTHER PT INFO: SEVERAL PTS INVOLVED, SAME TYPE OF EVENT INVOLVING THE AVEA DISPOSABLE WATER TRAP FRACTURING, NO ADVERSE OUT OUTCOME TO ANY OF THE PTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASYS 73CBK VENTILATOR, CONTINOUS (RESPIRATOR) CBK CAREFUSION 207, INC DISPOS FILTER/WATER TRAP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other