BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER

    MDR report key: 1842106 · Received August 24, 2010

    Report

    Report Number
    9611451-2010-00505
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVAL. WE WILL PROVIDE A F/U REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSP IN (B)(6) REPORTED THAT A HAIRLINE CRACK DEVELOPED IN THE BASE OF AN MR290HFV CHAMBER, RESULTING IN A WATER LEAK. THE HOSP STATED THAT THEY ARE HAVING A GENERAL PROBLEM WITH CRACKING MR290HFV CHAMBERS. NO PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290HFV 090912

    Patients

    Seq Age Sex Outcome Treatment
    1