BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3771280 · Received April 24, 2014

    Report

    Report Number
    9611451-2014-00370
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 26, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A BREAK IN THE WATER FEEDSET TUBE AT THE BAG SPIKE CONNECTION. THE SURFACE OF THE BREAK IS ROUGH (NOT SMOOTHLY CUT). A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 130819. CONCLUSION: THE OBSERVED DAMAGE APPEARS TO BE CAUSED BY THE TUBE BEING PULLED AWAY FROM THE BAG SPIKE, POSSIBLY DUE TO THE FEEDSET TUBE BEING CAUGHT OR PUT UNDER TENSION. WE HAVE CONDUCTED EXTENSIVE TESTING OF THE MR290 CHAMBER, WITH PARTICULAR EMPHASIS ON FEEDSET BREAKS. SIGNIFICANTLY WE HAVE NOT BEEN ABLE TO REPLICATE FAILURE OF THE FEEDSET TUBE AT THE CHAMBER DOME OR WATER BAG SPIKE IN ANY OF OUR TESTING. THE SPECIFICATION FOR THE CHAMBER REQUIRES THAT THE FEEDSET TUBE SHOULD HAVE A BREAKING STRAIN OF 30 NEWTONS. DURING PRODUCTION, PULL TESTING OF THE FEEDSET STRENGTH AT BOTH SPIKE AND DOME END IS PERFORMED EVERY HOUR ON MR290 CHAMBERS FROM EACH PRODUCTION LINE. IF ANY FAULTS ARE DETECTED THE WHOLE BATCH IS PLACED ON HOLD FOR INVESTIGATION. ADDITIONALLY ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. CHAMBERS THAT FAIL ANY OF THESE TESTS ARE DISCARDED. THIS SUGGESTS THAT THE PROBLEM OCCURRED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. 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.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT WATER LEAKED FROM THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER. THEY FURTHER REPORTED DAMAGE TO THE WATER FEEDSET TUBE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT WATER LEAKED FROM THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER. THEY FURTHER REPORTED DAMAGE TO THE WATER FEEDSET TUBE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249067 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1309090105

    Patients

    Seq Age Sex Outcome Treatment
    1 FPH RT340 ADULT BREATHING CIRCUIT| FPH RT340 ADULT BREATHING CIRCUIT