BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3112592 · Received May 14, 2013

    Report

    Report Number
    9611451-2013-00384
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 15, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290 CHAMBER IS CURRENTLY IN TRANSIT TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON RECEIPT OF THE COMPLAINT DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 DEVICE WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE COMPLAINT CHAMBER DOME WAS CRACKED IN SEVERAL PLACES. THE LARGEST CRACK STARTS BELOW THE BRACKET AND STRETCHES UPWARDS. OTHER SMALLER CRACKS WERE FOUND BETWEEN THE BRACKET AND ONE OF THE PORTS, STARTING FROM THE BASE AND STRETCHING UPWARDS. THE CRACKS DO NOT SHOW SIGNS OF STRESSMARKS. CONCLUSION: WE WERE UNABLE TO DETERMINE THE ROOT CAUSE OF THE CRACKS. EVERY MR290 CHAMBER IS PRESSURE TESTED TO (B)(4) FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS ANY OF THESE TESTS IS REJECTED. THIS SUGGESTS THAT THE CRACK DAMAGE OCCURRED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIDIFICATION 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." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT A WATER LEAK OCCURRED AT THE CONNECTION BETWEEN THE DOME AND THE BASE PLATE OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT A WATER LEAK OCCURRED AT THE CONNECTION BETWEEN THE DOME AND THE BASE PLATE OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213321 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1207050304

    Patients

    Seq Age Sex Outcome Treatment
    1