BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW VOLUME HUMIDIFICATION CHAMBER W/FLOAT &

    MDR report key: 950126 · Received November 16, 2007

    Report

    Report Number
    9616567-2007-00027
    Event Type
    Malfunction
    Date Received
    November 16, 2007
    Report Date
    October 17, 2007
    Manufacturer
    SMITHS MEDICAL
    Product Code
    BTT
    PMA / PMN Number
    K993282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT CODE # 1113014. TWO LOTS WERE REPORTED. 36F26M006 WAS MANUFACTURED 06/06 AS REPORTED. 1113014 WAS MANUFACTURED 03/07. SAMPLES HAVE BEEN RECEIVED FROM THE CUSTOMER; HOWEVER, SMITHS HAS NOT COMPLETED ITS INVESTIGATION INTO THIS ISSUE. A FOLLOW UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    REPORTER REPORTED TO SMITHS MEDICAL THAT THE FEED LINE IS DETACHING FROM THE CHAMBER WHEN PULLED SLIGHTLY. THERE WAS NO PATIENT INJURY OR TREATMENT REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW VOLUME HUMIDIFICATION CHAMBER W/FLOAT & ACCESSORIES FOR HEATED HUMIDIFIERS BTT SMITHS MEDICAL NA 36F26M006

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR