BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2972926 · Received February 21, 2013

    Report

    Report Number
    9611451-2013-00135
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT MR290 DEVICES FROM THE HOSPITAL. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE COMPLAINT DEVICES AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT FIVE MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE LEAKING WATER AT THE CONNECTION BETWEEN THE CHAMBER DOME AND THE CHAMBER BASE PLATE AFTER APPROXIMATELY 3-4 DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76211 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120809

    Patients

    Seq Age Sex Outcome Treatment
    1