BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 3042385 · Received March 25, 2013

    Report

    Report Number
    2021710-2013-00018
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 24, 2012
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K031745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUSION SENT A LETTER VIA EMAIL TO THE USER FACILITY SEEKING ADD'L INFO CONCERNING THE REPORTED EVENT AND THE CONDITION OF THE PT. AS OF (B)(4) 2013, THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. THE USER FACILITY DID NOT PROVIDE ANY PT OR DEVICE CODES ON THEIR USER FACILITY REPORT. CODES WERE DERIVED BASED ON THE INFO PROVIDED BY THE USER FACILITY MEDWATCH REPORT RECEIVED FROM THE FDA ON (B)(6) 2013 AND INFO DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP ON (B)(4) 2012. THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION FACTORY SERVICE REP. THE CAREFUSION FACTORY SERVICE REP 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 CAREFUSION FACTORY SERVICE REP RAN THE DEVICE THROUGH A COMPLETE CHECKOUT PER THE OPERATOR'S AND SERVICE MANUALS. UPON COMPLETION THE DEVICE WAS RETURNED TO THE CUSTOMER TO BE PLACED BACK INTO SERVICE. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH USER FACILITY REPRESENTATIVE(S) ON (B)(6) 2012. "[NAME REMOVED] CALLED TO REPORT THAT HE WAS TOLD THAT THIS SIPAP NEEDED TO BE EVALUATED BY CAREFUSION BECAUSE IT WAS NOT "WORKING RIGHT". HE INQUIRED FOR ADD'L INFO AND ALL HE WAS TOLD WAS THAT IN BIPHASIC MODE, THE UNIT WOULDN'T HOLD PRESSURE AND THAT IT SEEMED LIKE IT WAS "GIVING BREATHS". I EXPLAINED ABOUT THE "BIPHASIC MODE" AND HOW IT CAN APPEAR TO BE GIVING BREATHS. I ALSO EXPLAINED TO HIM THAT THIS UNIT CAN BE SENT IN OR HE CAN TRY TO VERIFY THEIR COMPLAINT USING THE USER VERIFICATION TEST PROVIDED IN THE OPERATOR'S AND SERVICE MANUALS. HE AGREED. HE WILL CHECK WITH RESPIRATORY IF IT WILL BE OKAY FOR HIM TO CHECK OUT THE UNIT. IF THEY INSIST THAT THIS UNIT BE SENT IN FOR EVAL, HE WILL CALL BACK TO REQUEST A RMA NUMBER." "[NAME REMOVED] CALLED BACK TO REPORT THAT RESPIRATORY WOULD RATHER HAVE CAREFUSION EVALUATE THE UNIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121930 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE / CBK CBK CAREFUSION SIPAP ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA ASKU