BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 6175935 · Received December 15, 2016

    Report

    Report Number
    9611451-2016-00854
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    December 2, 2016
    Report Date
    December 5, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE TWO COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS ARE EXPECTED BUT HAVE NOT YET BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION, TO DETERMINE IF THEY HAD A MALFUNCTION WHICH CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE WILL SUBMIT A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE 1: LOT 160907, DATE OF MANUFACTURE - SEPTEMBER 07, 2016, DEVICE 2: LOT 160811, DATE OF MANUFACTURE - AUGUST 11, 2016. METHOD: THE TWO COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION WHERE THEY WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF DEVICE 1 REVEALED NO EVIDENCE OF DAMAGE TO THE CHAMBER DOME. VISUAL INSPECTION OF DEVICE 2 REVEALED A HORIZONTAL CRACK AROUND THE BASE OF THE CHAMBER DOME AS WELL AS A CRACK BETWEEN THE HINGE BAFFLE AND THE OTHER PORT. A SMEARED PRINT WAS ALSO FOUND ABOVE THE CRACK OF DEVICE 2. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THE LOT NUMBER PROVIDED. CONCLUSION: THE NATURE OF THE CRACKING ON DEVICE 2 AND THE RESIDUE PRESENT INDICATES THAT THE CHAMBER DOME CAME INTO CONTACT WITH A SOLUTION CONTAINING ALCOHOL WHICH HAS RESULTED IN ENVIRONMENTAL STRESS CRACKING OF THE CHAMBER DOME. EVERY MR290 CHAMBER IS PRESSURE TESTED TO 200 CMH2O FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. THE SUBJECT MR290 HUMIDIFICATION CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE THE FOLLOWING: - DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS. - SET APPROPRIATE VENTILATOR ALARMS. - PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. - MAXIMUM OPERATING PRESSURE: 8 KPA.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS OF TWO RT324 INFANT CONTINUOUS FLOW BREATHING CIRCUITS BEGAN TO LEAK. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS OF TWO RT324 INFANT CONTINUOUS FLOW BREATHING CIRCUITS BEGAN TO LEAK. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825931 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 160811

    Patients

    Seq Age Sex Outcome Treatment
    1 RT324 INFANT CONTINUOUS FLOW BREATHING CIRCUIT