BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3746991 · Received April 11, 2014

    Report

    Report Number
    9611451-2014-00324
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT DEVICES FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED DEVICES: 3 X MR290V, LOT 130624, DATE OF MANUFACTURE: 24 JUNE 2013; 1 X MR290V, LOT 130816, DATE OF MANUFACTURE: 16 AUGUST 2013; 1 X MR290V, LOT 130314, DATE OF MANUFACUTRE: 14 MARCH 2013; 1 X MR290V, LOT 130829, DATE OF MANUFACTURE: 29 AUGUST 2013. METHOD: SIX MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE THEY WERE VISUALLY INSPECTED. RESULTS: ALL SIX OF THE CHAMBERS WERE CRACKED NEAR THE BASE AND THE PRINT AROUND THE CRACKS WAS SMEARED. ONE OF THE CHAMBERS HAD A VERTICAL CRACK ON THE SIDE OF THE DOME. WHITE RESIDUE WAS FOUND NEAR THE CRACKS ON FOUR CHAMBERS. FIVE OF THE CHAMBERS WERE ALSO NOTED TO HAVE DENTS ON THE BASE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOTS 130624, 130816, 130314 & 130829. CONCLUSION: THE SMEARED PRINT AND WHITE RESIDUE SUGGEST 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 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. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT SOME MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE DAMAGED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT SOME MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE DAMAGED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221306 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 130624

    Patients

    Seq Age Sex Outcome Treatment
    1