BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2161108 · Received July 13, 2011

    Report

    Report Number
    9611451-2011-00417
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 17, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): METHOD: TWO COMPLAINT MR290V VENTED AUTOFEED HUMIDIFIERS WITH DIFFERENT LOT NUMBERS WERE RETURNED TO FPH NEW ZEALAND FOR INVESTIGATION. BOTH RETURNED CHAMBERS WERE VISUALLY INSPECTED FOR CRACKS. RESULTS: A VISUAL INSPECTION REVEALED THAT BOTH CHAMBERS WERE CRACKED BUT NO STRESS MARKS WERE OBSERVED. THE CHAMBER WITH LOT NUMBER 110331 WAS CRACKED AT THE BOTTOM OF THE CHAMBER DOME, JUST BELOW THE BRACKET. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. THE CHAMBER WITH LOT NUMBER 110323 WAS CRACKED FROM ONE OF THE PORTS AND IT STRETCHED TO THE BASE OF THE DOME. ANOTHER CRACK WAS FOUND ALONG THE BASE, WHICH WAS BELOW THE CRACKED PORT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: CRACKS IN THE CHAMBER DOME MAY OCCUR IF THE CHAMBER IS IMPACTED OR USED OUTSIDE OF THE RECOMMENDED SETTINGS. HOWEVER, WE WERE UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM OBSERVED BY THE HEALTHCARE FACILITY AND IT IS UNLIKELY THAT THE CRACKS TO THE RETURNED CHAMBERS WERE PRESENT AT THE TIME OF PRODUCTION. 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 CHAMBER IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVED THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WATER STARTED TO LEAK FROM THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER, WHICH IS INCLUDED IN THE RT224 INFANT CONTINUOUS FLOW BREATHING CIRCUIT KIT, AFTER ABOUT 24 HOURS OF 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 WATER STARTED TO LEAK FROM THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER, WHICH IS INCLUDED IN THE RT224 INFANT CONTINUOUS FLOW BREATHING CIRCUIT KIT, AFTER ABOUT 24 HOURS OF 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 110323, 110331

    Patients

    Seq Age Sex Outcome Treatment
    1