BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3942155 · Received July 17, 2014

    Report

    Report Number
    9611451-2014-00626
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 30, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICES WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE COMPLAINT DEVICES WERE DISPOSED OF BY THE HOSPITAL. THEREFORE, OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE DISTRIBUTOR AND OUR KNOWLEDGE OF THE PRODUCT. THE DISTRIBUTOR REPORTED THAT THE WATER FEEDSET TUBE OF FOUR MR290HFV AUTOFEED HUMIDIFICATION CHAMBERS HAD BEEN DISCOVERED DAMAGED AT THE CHAMBER DOME CONNECTION. WITHOUT THE RETURN OF THE COMPLAINT DEVICES WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM EXPERIENCED BY THE CUSTOMER. 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 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 PRODUCT FAILS THIS TEST, THE WHOLE BATCH IS PLACED ON HOLD FOR INVESTIGATION. THE HEALTHCARE FACILITY REPORTED THAT THE COMPLAINT CHAMBERS WERE IN USE WHEN THE DAMAGE WAS OBSERVED, WHICH INDICATES THAT THE WATER FEEDSETS BECAME DAMAGED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED. 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 DISTRIBUTOR IN (B)(4) REPORTED THAT THE WATER FEEDSETS OF FOUR MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE DAMAGED AT THE CHAMBER CONNECTION. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420248 VENTED AUTOFEED CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290HFV

    Patients

    Seq Age Sex Outcome Treatment
    1