BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRD

    MDR report key: 1022828 · Received March 6, 2008

    Report

    Report Number
    2021710-2008-00013
    Event Type
    Malfunction
    Date Received
    March 6, 2008
    Date of Event
    July 22, 2006
    Report Date
    March 5, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY MEDWATCH REPORT INDICATES THAT THE EVENT OCCURRED IN 2006, THE DATE OF THEIR MEDWATCH REPORT IS 9/27/2006 AND THE REPORT INDICATES THAT THEY SUBMITTED THE REPORT TO THE FDA ON 1/2008. THIS EVENT OCCURRED OVER 18 MONTHS AGO AND THE REPORT INDICATES THAT THE DEVICE WAS REPAIRED AND APPARENTLY RETURNED TO SVC. CARDINAL HEALTH SENT A LETTER TO THE USER FACILITY SEEKING ADD'L INFO CONCERNING THE EVAL AND REPAIR OF THE DEVICE BY THE THIRD PARTY SVC CO TO INCLUDE REQUESTING A COPY OF THE ASSOCIATED SVC REPORT. AS OF THE DATE OF THIS REPORT THERE HAS BEEN ON RESPONSE FROM THE USER FACILITY. THE INFO PROVIDED ON THE USER FACILITY MEDWATCH REPORT INDICATES THAT THE DEVICE ALARMED APPROPRIATELY TO ALERT THE STAFF THAT THERE WAS A PROBLEM WITH THE DEVICE AND THE STAFF WAS ABLE TO RESPOND APPROPRIATELY, THUS THERE WERE NO CONSEQUENCES OR ADVERSE IMPACT TO THE PT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT REC'D FROM THE FDA VIA VIASYS MEDSYSTEMS ON 02/05/2008. "EVENT DESC: VENTILATOR ATTACHED TO PT IN ER AND FAILED TO OPERATE SEVERAL TIMES. THERE WAS A LOUD SHRILL ALARM AND THE ABSENCE OF BILATERAL BREATH SOUNDS. THE DR WAS PRESENT AND UNABLE TO GET THE VENTILATOR TO OPERATE ADEQUATELY. THE PT WAS BAGGED AS NEEDED AND DID NOT SUFFER ANY INJURY OR DETERIORATION IN CONDITION DUE TO THE PROBLEM. THE PT WAS TRANSFERRED TO ANOTHER FACILITY. RESPIRATORY THERAPY WAS CONSULTED AFTER OCCURRENCE. THE VENTILATOR IS IN THEIR CARE AND THEY WILL CLEAN IT AND CHECK IT TO SEE IF THERE CONTINUES TO BE A PROBLEM WITH SVC. THE VENTILATOR WAS SENT TO AN OUTSIDE VENDOR WHERE THERE WAS FOUND A LOOSE WIRE INSIDE THE VENTILATOR AND REPAIRED. THERE HAVE BEEN NO FURTHER PROBLEMS. DID THIS EVENT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE? NO. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIRD CONTINUOUS VENTILATOR CBK CARDINAL HEALTH 207, INC. 6400ST *

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR