BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL FEED ADULT HUMIDIFICATION CHAMBER

    MDR report key: 2991788 · Received March 6, 2013

    Report

    Report Number
    9611451-2013-00164
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    January 9, 2013
    Report Date
    February 5, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K913368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR250 MANUAL FEED HUMIDIFICATION CHAMBERS WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE HAVE MADE SEVERAL ATTEMPTS TO OBTAIN FURTHER INFORMATION REGARDING THE REPORTED INCIDENT. HOWEVER WE DID NOT RECEIVE ANY FURTHER INFORMATION. WITHOUT THE RETURN OF THE COMPLAINT DEVICES WE ARE UNABLE TO DETERMINE THE CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER. ALL CHAMBERS ARE PRESSURE TESTED AND VISUALLY INSPECTED PRIOR TO LEAVING THE PRODUCTION FACILITY . ANY CHAMBERS THAT FAIL ARE REJECTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR250 MANUAL FEED HUMIDIFICATION CHAMBERS STATE THE FOLLOWING: "IN THE EVENT OF THE CHAMBER LEAKING, SWITCH THE HUMIDIFIER OFF AND REPLACE THE CHAMBER." "ENSURE THAT THE WATER LEVEL IN THE CHAMBER IS PERIODICALLY MONITORED. REFILL WHEN NECESSARY."

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF GATHERING FURTHER INFORMATION REGARDING THE REPORTED INCIDENT. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT WATER LEAKED FROM TWO MR250 MANUAL FEED HUMIDIFICATION CHAMBERS WHEN THEY WERE USED ON A HIGH FREQUENCY VENTILATOR. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT WATER LEAKED FROM TWO MR250 HUMIDIFICATION CHAMBERS WHEN THEY WERE USED ON A HIGH FREQUENCY VENTILATOR. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94999 MANUAL FEED ADULT HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR250 120209

    Patients

    Seq Age Sex Outcome Treatment
    1