BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS

    MDR report key: 5186011 · Received October 28, 2015

    Report

    Report Number
    2021710-2015-02075
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Date of Event
    September 17, 2015
    Report Date
    October 12, 2015
    Manufacturer
    CAREFUSION
    Product Code
    BTY
    PMA / PMN Number
    K942211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS PERFORMED BY A CAREFUSION FAILURE ANALYSIS TECHNICIAN ON THE DELL XE2 COMPUTER. THE REPORTED COMPLAINT WAS DUPLICATED BY POWERING UP THE COMPUTER AND THE SCREEN SHOWED ¿WINDOWS COULD NOT START BECAUSE OF A COMPUTER DISK HARDWARE CONFIGURATION PROBLEM.¿ THIS BEHAVIOR WAS FOUND TO OCCUR IF THE DEFAULT VALUE IN THE BOOT.INI FILE IS MISSING OR INVALID, WINDOWS XP IS NOT INSTALLED IN THE LOCATION SPECIFIED IN THE BOOT.INI FILE, THE NTOSKRNL.EXE FILE IS MISSING OR DAMAGED, THE PARTITION PATH IN THE BOOT.INI FILE IS NOT SET CORRECTLY OR BECAUSE OF A GENERAL HARDWARE FAILURE. IN CONCLUSION, IT WAS DETERMINED THAT THERE WAS AN ISSUE WITH THE HARDWARE CONFIGURATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ONCE THE DEVICE IS RETURNED FOR EVALUATION AND ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP WILL BE SUBMITTED. CAREFUSION CONTINUES TO TRACK AND TREND ANY INCIDENT RELATED TO THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED EXPERIENCING COMPUTER FREEZE-UPS THAT WERE OCCURRING 2-3 TIMES A WEEK. DURING A TREADMILL TEST, ONE OF THEIR PROTOCOL SETTINGS WAS NOT TRANSFERRED CORRECTLY. THE TREADMILL SPEED WAS SUPPOSED TO BE SET AT 0.6 MPH AND IT JUMPED UP TO 2.5 MPH ON AN ELDERLY LADY. SHE DID NOT FALL NOR WAS THERE ANY INCIDENT RESULTING FROM THIS AS THE THERAPIST WAS ABLE TO MANUALLY DECREASE THE SPEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713094 VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION BTY CAREFUSION 229 E

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR