BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3756060 · Received April 17, 2014

    Report

    Report Number
    9611451-2014-00352
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE THREE COMPLAINT DEVICES WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4). THE COMPLAINT DEVICES WERE DISPOSED BY THE HOSPITAL. THEREFORE, OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL AND OUR KNOWLEDGE OF THE PRODUCT. THE HOSPITAL REPORTED THAT THE WATER FEEDSET TUBE OF THREE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS HAD DISCONNECTED FROM THE WATER BAG SPIKE. TWO OF THE CHAMBERS HAD LOT DATE 131013 (13 OCTOBER 2013) AND NO LOT DATE WAS PROVIDED FOR THE THIRD CHAMBER. 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 HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE WATER FEEDSET OF THREE MR290 AUTOFEED HUMIDIFICATION CHAMBERS BECAME DETACHED FROM THE WATER BAG SPIKE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234172 VENTED AUTOFEED CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 131013

    Patients

    Seq Age Sex Outcome Treatment
    1