BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAR

    MDR report key: 740400 · Received July 17, 2006

    Report

    Report Number
    2021710-2006-00053
    Event Type
    Malfunction
    Date Received
    July 17, 2006
    Date of Event
    May 14, 2006
    Report Date
    July 17, 2006
    Manufacturer
    VIASYS RESPIRATORY CARE INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LETTER WAS SENT VIA FAX TO THE HOSP IN A FOREIGN COUNTRY, REQUESTING ADD'L INFO ON THE REPORTED EVENT AND STATUS OF THE PT. ADDITIONALLY, WE HAVE REQUESTED THAT THE HOSP RETURN THE UNIT TO US FOR A COMPLETE EVAL. AS OF JULY 17, 2006 THERE HAS BEEN NO REPLY TO THE LETTER AND THE UNIT HAS NOT BEEN REC'D AS OF YET.

    Description of Event or Problem · 1

    THE NURSE HAPPENED TO BE IN THE WARD WITH THE PT. ALL OF A SUDDEN SHE HEARD THAT THERE WAS NO AIR COMING OUT OF THE VENTILATOR, BY HEARING NO AIR FLOW. THERE WAS NO ALARM AT THAT TIME. SHE IMMEDIATELY TOOK CARE OF THE PT. DISCONNECTED AND RECONNECTED THE PT FOR TRYING THE VENTILATOR TO CONTINUE, RESTART CYCLING AGAIN. UNFORTUNATELY THIS DID NOT HAPPEN. AT THAT MOMENT, NO ALARM WAS TRIGGERED, NOT AUDIBLE, NOT VISIBLE. THEN SHE RESTARTED THE VENTILATOR BY SWITCHING THE MAIN POWER SWITCH OFF AND ON. THERE STILL WAS NO VENTILATION, NOR ANY ALARM. THEY WERE NOT ABLE TO START THE TEST PROGRAM. AFTER SOME TIME, A WAY TOO LONG TIME, A CONTINUOUS BUT WEAK AUDIBLE ALARM COULD BE HEARD, AND ALSO THE ALARM "FAILED TO CYCLE" WAS VISIBLE. SINCE THEY WERE NOT ABLE TO RUN THE TEST PROGRAM, NO ERROR CODE ('EXX') VISIBLE. ACCORDING TO THE NURSE AND HOSP TECHS, THERE WAS NOTHING WRONG WITH THE MACHINE AS FAR AS THEY COULD SEE IT. ALL LINES, FILTERS, TUBES, ETC. HAVE BEEN CHECKED, NOTHING WAS WRONG, EVERYTHING WAS CONNECTED AS IT SHOULD. AT FIRST THEY CONTINUED VENTILATING THE PT BY HAND, AND MEANWHILE PREPARED ANOTHER BEAR1000 FOR CONTINUATION OF TREATMENT. ALTHOUGH RUMORS SAID SO, THANK GOD, THERE WAS NO NEED FOR REANIMATION. THE NURSE TOLD US THAT IF SHE DID NOT HAPPEN TO BE IN THE WARD WHEN THIS ALL HAPPENED, THE PT WOULD HAVE DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAR VOLUME VENTILATOR CBK VIASYS RESPIRATORY CARE INC. BEAR 1000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention