BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2103255 · Received May 25, 2011

    Report

    Report Number
    9611451-2011-00315
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290UX 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). THE COMPLAINT MR290UX HAD BEEN DESTROYED AT THE HOSPITAL. AN ATTEMPT WAS MADE TO OBTAIN FURTHER INFORMATION FROM THE HOSPITAL IN ORDER TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE REPORTED COMPLAINT BUT NO REPLY WAS RECEIVED FROM THEM. WITHOUT THE COMPLAINT DEVICE OR ADDITIONAL INFORMATION FROM THE HOSPITAL WE ARE UNABLE TO CONFIRM THE REPORTED FAULT. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290 HUMIDIFICATION CHAMBER STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARM." "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 HEALTHCARE FACILITY IN (B)(6) REPORTED THAT AN MR290UX AUTOFEED HUMIDIFICATION CHAMBER DID NOT FILL WATER WHEN CONNECTED TO A WATERBAG. THIS WAS NOTICED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT AN MR290UX AUTOFEED HUMIDIFICATION CHAMBER DID NOT FILL WATER WHEN CONNECTED TO A WATERBAG. THIS WAS NOTICED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290UX NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1