BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3895503 · Received June 25, 2014

    Report

    Report Number
    9611451-2014-00561
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 29, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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

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

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT (B)(4) CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: INSPECTION OF THE COMPLAINT FEEDSET TUBE AND WATER BAG SPIKE REVEALED THAT THE FEEDSET TUBING WAS COMPLETELY SEPARATED FROM THE SPIKE. THERE WAS SUFFICIENT GLUE PRESENT ON BOTH COMPONENTS. CONCLUSION: WE WERE UNABLE TO DETERMINE DEFINITIVELY THE ROOT CAUSE OF THE REPORTED FAULT. OUR PREVIOUS INVESTIGATION OF SIMILAR COMPLAINTS HAVE SHOWN THAT SUCH PROBLEMS HAVE BEEN CAUSED BY THE USER REMOVING THE SPIKE BY GRASPING THE TUBING INSTEAD OF THE SPIKE. WE HAVE CONDUCTED EXTENSIVE TESTING OF THE (B)(4) 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 (B)(4) NEWTONS. DURING PRODUCTION, PULL TESTING OF THE FEEDSET STRENGTH AT BOTH SPIKE AND DOME END IS PERFORMED EVERY HOUR ON (B)(4) CHAMBERS FROM EACH PRODUCTION LINE. 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. THE USER INSTRUCTIONS WHICH ACCOMPANY THE (B)(4) 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." OUR MONITORING AND TRENDING OF COMPLAINTS OF LOOSE WATER BAG SPIKES ON (B)(4) FEEDSETS HAS A RATE OF OCCURRENCE OF (B)(4) DEVICES PER MILLION SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF (B)(6) 2014.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT DISTILLED WATER WAS LEAKING FROM AN MR290 AUTOFEED HUMIDIFICATION CHAMBER WATER FEEDSET. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT DISTILLED WATER WAS LEAKING FROM AN (B)(4) AUTOFEED HUMIDIFICATION CHAMBER WATER FEEDSET. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370399 VENTED AUTOFEED CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 120510

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE RT340 BREATHING CIRCUIT| FISHER & PAYKEL HEALTHCARE RT340 BREATHING CIRCUIT