BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABYTHERM 8000WB

    MDR report key: 4120726 · Received July 22, 2014

    Report

    Report Number
    9611500-2014-00043
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    FMT
    PMA / PMN Number
    K945467
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THAT DUE TO WEAR AND TEAR OF THE CORRESPONDING TOOL THE GUIDANCE GROOVES LOCATED AT THE CORNERS OF THE DEVICE DO NOT MATCH SPECIFICATION. AS CONSEQUENCE AN ADDITIONAL FORCE IS REQUIRED TO PUSH THE SIDE WINDOWS INTO THE CORRECT POSITION. THE INSTRUCTIONS FOR USE ADVISE THE USERS TO ENSURE AND CHECK THE PROPER POSITIONING OF THE SIDE WINDOWS. A SAMPLE TEST WAS PERFORMED AND IT COULD BE CONFIRMED THAT AN ADDITIONAL FORCE IS REQUIRED AS REPORTED. IT WAS FOUND THAT NOT ALL USERS ARE AWARE OF THAT. ADDITIONALLY THE SAMPLE TEST REVEALED THAT NOT IN ALL CASES THE INNER WINDOWS WERE USED AS DESCRIBED IN THE INSTRUCTIONS FOR USE. IN CASE A SIDE WINDOW IS NOT LOCATED IN THE CORRECT POSITION ( AND THE INNER WINDOWS ARE NOT USED) THERE IS A POSSIBILITY THAT IT MAY BE OPENED DUR TO VIBRATION OR A HIT BY THE BABY. IN THIS CASE THE BABY MIGHT FALL OUT OF THE WARMER. BY NOW NO OTHER CASES IN CONTEXT WITH THE ABOVE MENTIONED ROOT CAUSE HAVE BEEN REPORTED. HENCE WE DECIDED TO INFORM THE USERS ABOUT THE CORRECT POSITIONING OF THE SIDE WINDOWS AND THE USAGE OF THE INNER WINDOWS AS DESCRIBED IN THE INSTRUCTIONS FOR USE. THE CORRESPONDING SAFETY NOTICE IS SCHEDULED TO BE PUBLISHED BY END OF (B)(4) 2014, LATEST. THE COMPETENT AUTHORITIES OF THE AFFECTED COUNTRIES WILL BE INFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDANCE GROOVES LOCATED AT THE CORNERS OF AN INFANT WARMER ARE TOO SMALL. AS A CONSEQUENCE THE SIDE WINDOWS DO NOT SLIDE IN BY THEMSELVES AS EXPECTED. THE USER HAS TO APPLY AN ADDITIONAL FORCE TO ENSURE THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429265 BABYTHERM 8000WB NA FMT DRAEGER MEDICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other