BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2223806 · Received August 25, 2011

    Report

    Report Number
    9611451-2011-00520
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 1, 2011
    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) LOT NUMBER: 110421, DEVICE MANUFACTURE DATE: 04/21/2011, QUANTITY: 1; 110208, 02/08/2011, 1; 110121, 01/21/2011, 1; 110324, 03/24/2011, 2. METHOD: FIVE COMPLAINT MR290V CHAMBERS WERE RECEIVED AND VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE CHAMBER DOMES WERE CRACKED IN SEVERAL PLACES; HOWEVER, NONE OF THE CRACKS SHOWED STRESS MARKS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110421. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110208. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110121. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 110324. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM OBSERVED BY THE HEALTHCARE FACILITY. EVERY MR290 CHAMBER IS PRESSURE TESTED TO 200CMH20 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. THIS SUGGESTS THAT THE CRACKS OCCURRED POST PRODUCTION. FISHER & PAYKEL HEALTHCARE'S USER INSTRUCTIONS THAT ACCOMPANY THE MR290 CHAMBER SPECIFY TO THE USER TO "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT", TO REFRAIN FROM USING THE CHAMBER IF IT HAS BEEN DROPPED AND "TO SET THE APPROPRIATE VENTILATOR ALARMS" IN THE EVENT A LEAK OCCURS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT SEVEN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS BECAME DAMAGED WHEN CONNECTED TO AN MR850 RESPIRATORY HUMIDIFIER. THIS WAS NOTICED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT SEVEN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS BECAME DAMAGED WHEN CONNECTED TO AN MR850 RESPIRATORY HUMIDIFIER. THIS WAS NOTICED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V REFER TO H10

    Patients

    Seq Age Sex Outcome Treatment
    1 MR850 RESPIRATORY HUMIDIFIER| (B)(4) INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT| (B)(4) INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT| MR850 RESPIRATORY HUMIDIFIER