BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1487078 · Received August 4, 2009

    Report

    Report Number
    9611451-2009-00412
    Event Type
    Malfunction
    Date Received
    August 4, 2009
    Report Date
    July 7, 2009
    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 MR290V HUMIDIFICATION CHAMBER IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE ('FHP') (B)(4) FOR INVESTIGATION. PHOTOGRAPHS OF THE COMPLAINT DEVICE WERE PROVIDED BY FPH'S OFFICE IN (B)(4). FROM THE EVENT DESCRIPTION AND PHOTOGRAPHS, THIS APPEARS TO BE AN IMPACT DAMAGE THAT LEADS TO MISALIGNMENT AND SUBSEQUENT JAMMING OF THE VALVE FLOAT MECHANISM, ALLOWING WATER TO FILL THE CHAMBER UNIMPEDED AND PREVENTING FLOAT OPERATION. THE SMALL DENT OBSERVED ON THE ALUMINIUM BASE INDICATES AN IMPACT AND IS CONSISTENT WITH THE DAMAGE USUALLY ASSOCIATED WITH OVERFILLING OF THE CHAMBER. THE MR290 USER INSTRUCTIONS INCLUDES A WARNING NOT TO USE THE CHAMBER IF IT HAS BEEN DROPPED. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE COMPLAINT DEVICE AND COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE ('FPH') FIELD REPRESENTATIVE THAT WHILE A BAG OF FLUID WAS ATTACHED TO AN MR290V HUMIDIFICATION CHAMBER, THE VALVE INSIDE THE CHAMBER DID NOT WORK, CAUSING THE WATER TO OVERFILL. THIS OCCURRED DURING PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290V 080426

    Patients

    Seq Age Sex Outcome Treatment
    1