BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 3103662 · Received May 9, 2013

    Report

    Report Number
    9611451-2013-00346
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 10, 2013
    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). LOT NUMBER: 120809, 121004; QUANTITY AFFECTED: (B)(4); MANUFACTURING DATE: 08/09/2012, 10/04/2012. METHOD: EIGHT COMPLAINT MR290VX CHAMBERS WERE RETURNED TO FPH IN (B)(4) AND WERE VISUALLY INSPECTED. OUR ANALYSIS IS ALSO BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL AND RESULTS OF PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS. RESULTS: VISUAL INSPECTION REVEALED THAT ALL CHAMBER DOMES WERE CRACKED ALONG THE BASE. THE HOSPITAL ALSO REPORTED THAT THE SUBJECT MR290VX CHAMBERS WERE BEING USED WITH A SIPAP VENTILATOR. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 120809. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 121004. CONCLUSION: WE WERE UNABLE TO DETERMINE DEFINITIVELY THE ROOT CAUSE OF THE REPORTED FAULT; HOWEVER, IT IS KNOWN THAT SIPAP VENTILATOR IS CAPABLE OF PRODUCING PRESSURES IN EXCESS OF (B)(4). THE INTEGRITY OF THE CHAMBERS CAN BE AFFECTED WHEN PRESSURES EXCEED (B)(4). 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. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS EITHER OF THESE TESTS IS REJECTED. THE SUBJECT MR290VX CHAMBERS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF RELEASE FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290 STATE THE FOLLOWING: "USE OF THE MR290 ABOVE THE MAXIMUM OPERATING PRESSURE [(B)(4)] MAY LEAD TO CRACKING, WATER LEAKAGE AND, ON RARE OCCASIONS COULD LEAD TO A LOSS OF VENTILATION PRESSURE". "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSION BEFORE CONNECTING TO A PATIENT". (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WATER LEAKED AT THE CONNECTION BETWEEN THE CHAMBER DOME AND ALUMINIUM BASE OF EIGHT MR290VX VENTED AUTOFEED HUMIDIFICATION CHAMBERS DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203545 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290VX SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1