BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 3580086 · Received January 16, 2014

    Report

    Report Number
    9611451-2014-00041
    Event Type
    Malfunction
    Date Received
    January 16, 2014
    Date of Event
    December 19, 2013
    Report Date
    December 19, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBER IS EXPECTED TO RETURN TO FISHER & PAYKEL HEALTHCARE IN (B)(4) BUT HAS NOT YET ARRIVED. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION REVEALED A HORIZONTAL CRACK WHICH STARTED AT THE BASE OF THE CHAMBER AND PRESENTED SMALLER CRACKS PROPAGATING FROM IT. THERE WERE NO SIGN OF RESIDUE IN THE DOME BUT THERE WERE STRESS MARKS PRESENT IN THE REGION OF THE CRACKS. A LOT CHECK WAS PERFORMED AND THERE WERE NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 130628. CONCLUSION:WE WERE UNABLE TO DETERMINE THE CAUSE OF THE DAMAGE. HOWEVER, IT IS KNOWN THAT PRESSURES PRODUCED IN EXCESS OF 80 CMH20 (8 KPA) MAY AFFECT THE INTEGRITY OF THE CHAMBER. EVERY MR290 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. THE CUSTOMER HAS REPORTED THAT THE CRACK APPEARED AFTER THE PRODUCT HAD BEEN IN USE, INDICATING THE FAULT WAS NOT PRESENT DURING SET UP. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE THE FOLLOWING: SET APPROPRIATE VENTILATOR ALARMS. PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. MAXIMUM OPERATING PRESSURE: 8 KPA.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT AN MR290V HUMIDIFICATION CHAMBER WAS FOUND TO BE CRACKED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT AN MR290V HUMIDIFICATION CHAMBER WAS FOUND TO BE CRACKED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43350 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1306280306

    Patients

    Seq Age Sex Outcome Treatment
    1