BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 3538934 · Received November 1, 2013

    Report

    Report Number
    2021710-2013-00072
    Event Type
    Malfunction
    Date Received
    November 1, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 1, 2013
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CAREFUSION (B)(4). UPON RECEIPT OF THE DEVICE, THE CAREFUSION (B)(4) PERFORMED AN VISUAL INSPECTION AND FOUND THAT THE DEVICE WAS MISSING THE FOLLOWING COMPONENTS THAT WERE IN USE WITH THE DEVICE AT THE TIME OF THE INCIDENT; EXHALATION VALVE BODY PN: 20005, EXHALATION VALVE DIAPHRAGM PN: 16240 AND EXHALATION FLOW SENSOR PN: 16496. THE CAREFUSION EUROPEAN SERVICE CENTER SERVICE REPRESENTATIVE REPLACED THESE PARTS IN ORDER TO EVALUATE THE DEVICE AND WAS UNABLE TO REPRODUCE/VERIFY THE COMPLAINT. THE CAREFUSION (B)(4) COULD NOT RULE ANY OF THEM OUT AS A POSSIBLE CONTRIBUTING FACTOR IN THE REPORTED EVENT. THUS NO ROOT CAUSE WAS DETERMINED. THE CAREFUSION (B)(4) RAN THE DEVICE THROUGH A COMPLETE CALIBRATION AND TESTING TO ENSURE THE DEVICE MET ALL FACTORY SPECIFICATIONS. UPON COMPLETION THE DEVICE WAS RETURNED TO THE DISTRIBUTOR READY TO BE RETURNED TO THE USER FACILITY READY TO BE PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS REPORTED TO CAREFUSION (B)(4) BY THE SURGICAL COMPANY (B)(4) THE DISTRIBUTOR IN (B)(6) AND RELAYED TO CAREFUSION (B)(4) VIA EMAIL. "THE VELA DID NOT SUPPLIED THE PATIENT WITH OXYGEN. EVERYTHING WAS SET AND ATTACHED CORRECTLY AS WELL THE UNIT WAS SHOWN EVERYTHING CORRECTLY AND NORMAL (LOOKED LIKE THE PATIENT IS GETTING VENTILATED), BUT THERE WAS NO OUTPUT FROM THE UNIT. IT HAS NO LEAKAGE OR SOMETHING LIKE THAT. THE PATIENT HAD TO BE BAGGED." THE FOLLOWING ADDITIONAL INFORMATION CONCERNING THE EVENT WAS COPIED FROM A LETTER RECEIVED FROM THE USER FACILITY ON (B)(4) 2013 THAT WAS IN RESPONSE TO A LETTER SENT BY CAREFUSION SEEKING ADDITIONAL INFORMATION. "IT HAPPENED IN THE WEEK 38. THE STAFF PUT THE PATIENT ONTO THE VELA (THE DOCTOR WAS WITH THEM). AFTER A SHORT TIME THE PATIENT DID NOT RECEIVE ANY OXYGEN. ACCORDING TO THE VELA IT WAS WORKING FINE AND NO ALARM WAS OCCURRING. BUT STILL THERE WAS NO OXYGEN DELIVERED TO THE PATIENT. THE PATIENT HAD TO BE BAGGED. WITH A REPLACEMENT UNIT WAS OKAY. THE USER FACILITY REPORTED THAT THE PATIENT (SAME PATIENT CIRCUIT)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564837 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE/CBK CBK CAREFUSION VELA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ASKU/ASKU