BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 5345496 · Received January 5, 2016

    Report

    Report Number
    9611451-2015-00568
    Event Type
    Malfunction
    Date Received
    January 5, 2016
    Date of Event
    December 4, 2015
    Report Date
    December 7, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ONE COMPLAINT MR290 CHAMBER WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WHERE IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A CRACK IN THE CHAMBER DOME UNDERNEATH ONE OF THE PORTS WITH THE PRESENCE OF STRESS MARKS. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS OF THIS NATURE FOR LOT 141129. CONCLUSION: THE HOSPITAL HAS INFORMED US THAT THE MR290 CHAMBER WAS BEING USED WITH A SIPAP VENTILATOR. THIS TYPE OF VENTILATOR IS CAPABLE OF PRODUCING PRESSURES IN EXCESS OF 80CMH2O. THE INTEGRITY OF THE CHAMBER CAN BE AFFECTED WHEN PRESSURES EXCEED 80CMH2O. WHEN QUESTIONED, THE HOSPITAL WAS UNABLE TO SUPPLY THE PRESSURE SETTINGS AT THE TIME OF THE EVENT. 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 CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290HFV STATE THE FOLLOWING: USE OF THE MR290 ABOVE THE MAXIMUM OPERATING PRESSURE [8KPA (~80CMH2O)] 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 OCCLUSIONS BEFORE CONNECTING TO A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA AN FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT A MR290 HUMIFICATION CHAMBER DOME BROKE AFTER 2 DAYS OF USE. IT WAS ALSO REPORTED THAT A SYNCHRONISED INTERMITTENT POSITIVE AIRWAY PRESSURE (SIPAP) VENTILATOR WAS USED IN SIPAP MODE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA AN FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT A MR290 HUMIFICATION CHAMBER DOME BROKE AFTER 2 DAYS OF USE. IT WAS ALSO REPORTED THAT A SYNCHRONISED INTERMITTENT POSITIVE AIRWAY PRESSURE (SIPAP) VENTILATOR WAS USED IN SIPAP MODE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4541 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1411290306

    Patients

    Seq Age Sex Outcome Treatment
    1