BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3942687 · Received July 17, 2014

    Report

    Report Number
    9611451-2014-00631
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 20, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT CHAMBERS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE THREE COMPLAINT MR290 CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WERE VISUALLY INSPECTED. THE LOT INFORMATION IS AS FOLLOWS: TWO FROM LOT 130807, MANUFACTURED 7 AUGUST 2013. ONE FROM LOT 131114, MANUFACTURED 14 NOVEMBER 2013. RESULTS: VISUAL INSPECTION REVEALED THAT ALL THREE COMPLAINT DEVICES HAD CRACKS NEAR THE BASE OF THE CHAMBER DOME. FOR ALL OF THE CHAMBERS THE PRINTING ON THE DOME WAS SLIGHTLY SMEARED. RESIDUE AND FLOW MARKS WERE OBSERVED ON ONE OF THE CHAMBERS. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR THE LOT DATES PROVIDED. CONCLUSION: THE SMEARED PRINT, FLOW MARK AND 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 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) DEVICES PER (B)(4) SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF JUNE 2014.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THREE MR290 AUTOFEED HUMIDIFICATION CHAMBERS LEAKED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THREE MR290 AUTOFEED HUMIDIFICATION CHAMBERS LEAKED DURING USE.NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418416 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE RT265 BREATHING CIRCUIT| FISHER & PAYKEL HEALTHCARE RT265 BREATHING CIRCUIT