BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2103235 · Received May 25, 2011

    Report

    Report Number
    9611451-2011-00311
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Report Date
    May 3, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS VISUALLY INSPECTED FOR DAMAGE AND PERFORMANCE TESTED BY CONNECTING TO A WATERBAG. RESULTS: NO DAMAGES WERE OBSERVED ON THE RETURNED CHAMBER. WHEN CONNECTED TO A WATERBAG, THE WATER FLOWED INTO THE CHAMBER NORMALLY. IT WAS FILLED SUCCESSFULLY AND STOPPED AT THE MAXIMUM WATER LEVEL LINE. CONCLUSION: NO FAULT WAS FOUND WITH THE RETURNED DEVICE. THE CHAMBER FUNCTIONED NORMALLY DURING TESTING. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT".

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT WHILE AN RT212 ADULT INSPIRATORY HEATED BREATHING CIRCUIT WAS BEING SET UP, THE HOSPITAL STAFF NOTICED THAT THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER "FLOODED". NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT WHILE AN RT212 ADULT INSPIRATORY HEATED BREATHING CIRCUIT WAS BEING SET UP, THE HOSPITAL STAFF NOTICED THAT THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER "FLOODED." NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 101115

    Patients

    Seq Age Sex Outcome Treatment
    1