BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3910994 · Received July 2, 2014

    Report

    Report Number
    9611451-2014-00584
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    May 15, 2014
    Report Date
    June 3, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 CHAMBER WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE PS159133 FOR EVALUATION. RESULTS: VISUAL INSPECTION REVEALED THAT THE CHAMBER DOME WAS CRACKED UNDERNEATH THE CHAMBER PORT. THE PRINT ABOVE THE CRACK AND BENEATH THE HINGE BRACKET WAS SLIGHTLY SMEARED. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR LOT DATE 130205. CONCLUSION: THE RESIDUE AROUND THE CRACK SUGGESTS THAT THE DAMAGE WAS CAUSED BY THE CHAMBER COMING INTO CONTACT WITH A SOLUTION CONTAINING ALCOHOL WHICH 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. 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 HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT AN MR290 AUTOFEED HUMIDIFICATION CHAMBER LEAKED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386151 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 130205

    Patients

    Seq Age Sex Outcome Treatment
    1