BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER

    MDR report key: 4754888 · Received May 7, 2015

    Report

    Report Number
    9611451-2015-00231
    Event Type
    Malfunction
    Date Received
    May 7, 2015
    Date of Event
    April 7, 2015
    Report Date
    April 7, 2015
    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). WE ARE IN THE PROCESS OF OBTAINING THE COMPLAINT DEVICES FOR EVALUATION. OUR INVESTIGATION IS IN PROGRESS AND WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THREE COMPLAINT MR290HFV CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE DOME OF ALL THREE CHAMBERS WAS CRACKED. ONE OF THE THREE CHAMBERS HAD A HORIZONTAL CRACK IN THE CHAMBER DOME UNDERNEATH THE PORT ALONG THE BASE AND THE CHAMBER DOME WAS CRACKED BESIDE THE HINGE BRACKET. THE OTHER TWO CHAMBERS EACH HAD A VERTICAL CRACK BESIDE THE HINGE BRACKET ON THE CHAMBER DOME. THE PRINT ON THE DOMES WAS SMEARED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 140409. CONCLUSION: THE NATURE OF THE CRACKING AND THE RESIDUE ON TWO OF THE CHAMBERS INDICATE THAT THE DAMAGE WAS CAUSED BY THE CHAMBERS COMING INTO CONTACT WITH A SOLUTION CONTAINING ETHANOL/ALCOHOL WHICH HAS RESULTED IN ENVIRONMENTAL STRESS CRACKING OF THE CHAMBER DOMES. 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. 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. OUR MONITORING AND TRENDING OF COMPLAINTS OF ENVIRONMENTAL STRESS CRACKING IN MR290 CHAMBERS HAS A RATE OF OCCURRENCE OF (B)(4) WORLDWIDE IN THE LAST YEAR TO THE END OF MARCH 2015.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THREE MR290HFV HUMIDIFICATION CHAMBERS WERE FOUND TO BE CRACKED DURING USE. THE CHAMBERS WERE ALL USED WITH HIGH-FREQUENCY OSCILLATORY VENTILATION (HFOV). THE FIRST EVENT OCCURRED ON (B)(6) 2015, THE SECOND EVENT OCCURRED ON (B)(6) 2015 AND THE THIRD EVENT OCCURRED ON (B)(6) 2015. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THREE MR290HFV HUMIDIFICATION CHAMBERS WERE FOUND TO BE CRACKED DURING USE. THE CHAMBERS WERE ALL USED WITH HIGH-FREQUENCY OSCILLATORY VENTILATION (HFOV). THE FIRST EVENT OCCURRED ON (B)(6) 2015, THE SECOND EVENT OCCURRED ON (B)(6) 2015 AND THE THIRD EVENT OCCURRED ON (B)(6) 2015. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300576 HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290HFV 1404090306

    Patients

    Seq Age Sex Outcome Treatment
    1 SENSORMEDICS HIGH FREQUENT OSCILLATOR| SENSORMEDICS HIGH FREQUENT OSCILLATOR