BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 4419048 · Received January 7, 2015

    Report

    Report Number
    2021710-2015-00005
    Event Type
    Malfunction
    Date Received
    January 7, 2015
    Date of Event
    December 8, 2014
    Report Date
    December 8, 2014
    Manufacturer
    CAREFUSION
    Product Code
    BTY
    PMA / PMN Number
    K981366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 12/17/2014, CAREFUSION BECAME AWARE THAT THERE WAS A SECOND SIMILAR EVENT INVOLVING ANOTHER PATIENT. CAREFUSION WILL SUBMIT A SEPARATE MEDWATCH FOR THAT EVENT. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. (B)(4). THE FOLLOWING INFO CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION FIELD SERVICE REP. THE CAREFUSION FIELD SERVICE REP EVALUATED THE DEVICE AND IN CONSULTATION WITH A CAREFUSION TECHNICAL SUPPORT REP DETERMINED THAT THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS AN ISSUE WITH THE MODEL: TMX425C TREADMILL, SN: (B)(4) MANUFACTURED BY (B)(4). THE CAREFUSION FIELD SERVICE REP ADVISED THE USER FACILITY TO CONTACT (B)(4) AND HAVE THEM COME IN AND EVALUATE THE TREADMILL. CAREFUSION CONTACTED (B)(4) AND THEY CONFIRMED THAT THE TMX425C TREADMILL, SN: (B)(4) WAS MANUFACTURED ON 12/31/2001. THEY FURTHER STATED THAT THIS PRODUCT IS NO LONGER MANUFACTURED BY THEM THOUGH IT IS STILL BEING SERVICES BY THEM AND IS NOT YET OBSOLETE. THE (B)(4) REP INDICATED THAT AN INTERMITTENT INTERFACE CABLE CAN CAUSE SPEED CHANGES AND RECOMMENDED THAT THE USER FACILITY HAVE THE TREADMILL CALIBRATED. FOR CUSTOMER SATISFACTION, CAREFUSION HAS SHIPPED THE USER FACILITY A NEW TREADMILL AND RECOMMENDED THAT THEY TAKE THE OLD TREADMILL OUT OF SERVICE.

    Description of Event or Problem · 1

    THE FOLLOWING INFO CONCERNING THE EVENT WAS DOCUMENTED BY CAREFUSION REP(S) IN RESPONSE TO PHONE CONVERSATION(S) WITH A CAREFUSION CLINICAL OPERATIONS MGR AND USER FACILITY REP(S). "[NAME REMOVED] CALLED IN STATES THE ACCOUNT IS COMPLAINING THE TM SPEEDS UPS AND RUNS TO FAST SAID THEY TALKED TO SOMEONE IN TECH SUPPORT??? [NAME REMOVED] HAS CHECKED THE PROTOCOLS THE ARE FINE [NAME REMOVED] STATES HE DID NOT SEE THIS HAPPEN". "SPOKE TO DR. SAYS HE THINKS IT IS A PEDS TM TM 425C SN (B)(4) SAYS THIS IS AN OLDER TM NOT THE SN IN OUR DATABASE MAYBE THE ITM NEEDS A FIRMWARE UPGRADE USING MPH AND NOT KPM SEES TM SPEED AS DOUBLED KIDS HAVE ALMOST BEEN THROWN OFF DR. STATES IS THIS HAPPEN ONCE MORE HE IS GOING TO CLOSE THE LAB DOWN SAYS THIS HAPPENED AFTER THE WIN7 UPGRADE". "THE CUSTOMER ADVOCATE MGR HAD A PHONE CONVERSATION WITH [NAME REMOVED] THE NURSE MGR AT THE USER FACILITY REGARDING THE TREADMILL ISSUE. NEITHER PATIENT (DESPITE BEING IN A COMPROMISED CARDIOVASCULAR AND/OR PULMONARY STATE) WAS HARMED AT THE TIME THE RAMP-UP OCCURRED. NO MEDICAL INTERVENTION WAS REQUIRED AT THE TIME. THE PATIENTS WERE BOTH ASSISTED OFF OF THE TREADMILL AND ALLOWED TO REST. ACCORDING TO [NAME REMOVED] NEITHER HAS BEEN TREATED FOR ANY OTHER ADVERSE EVENT RELATED TO THE SITUATION; HOWEVER, THE BELIEF IS THAT SHOULD THIS RECUR IT HAS THE POTENTIAL TO CAUSE HARM (RISK FOR SERIOUS INJURY OR DEATH)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13208 CAREFUSION CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION/B BTY CAREFUSION VMAX ENCORE 29C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI CAREFUSION ECGC CAM, SN: (B)(4)| FULL VERSION TREADMILL, SN: (B)(4)