BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2110701 · Received June 1, 2011

    Report

    Report Number
    9611451-2011-00324
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 6, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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). METHOD: THE THREE COMPLAINT CHAMBERS, ONE WITH LOT NUMBER 101222 AND TWO WITH LOT NUMBER 110211, WERE RETURNED AND VISUALLY INSPECTED. ONE OF THE COMPLAINT CHAMBERS WITH LOT NUMBER 110211 WAS RETURNED UNOPENED. RESULTS: NO DAMAGE WAS OBSERVED ON THE COMPLAINT CHAMBER, LOT NUMBER 110211, THAT HAD NOT BEEN OPENED OR USED. THE VISUAL INSPECTION OF THE OTHER TWO COMPLAINT CHAMBERS REVEALED A CRACK AT THE BOTTOM OF THE DOME, UNDERNEATH THE BRACKET AND ENDING NEAR THE BAFFLE. A SECOND CRACK WAS FOUND ABOVE THE BRACKET OF ONE OF THE COMPLAINT CHAMBERS. NO STRESS MARKS WERE OBSERVED ON EITHER OF THE CHAMBERS. A LOT CHECK REVEALED TWO OTHER COMPLAINTS OF SIMILAR NATURE FOR LOT NUMBER 101222. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF SIMILAR NATURE FOR LOT NUMBER 110211. CONCLUSION: EVERY (B)(4) 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. IT IS LIKELY THAT THE COMPLAINT CHAMBERS SUSTAINED THE REPORTED DAMAGE POST-PRODUCTION AS A RESULT OF ACCIDENTAL IMPACT DURING TRANSPORTATION OR STORAGE OF THE DEVICE. FISHER & PAYKEL HEALTHCARE'S USER INSTRUCTIONS THAT ACCOMPANY THE (B)(4) 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. OUR MONITORING AND TRENDING OF CRACKED (B)(4) CHAMBERS DUE TO IMPACT HAS A RATE OF OCCURRENCE OF 5 DEVICES PER MILLION SOLD WORLDWIDE IN THE LAST YEAR TO (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICES ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE, (B)(4). WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS WATER LEAKAGE FROM THREE MR290 AUTOFEED HUMIDIFICATION CHAMBERS DURING USE WITH AN RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT. THE HOSPITAL HAS FURTHER REPORTED THAT THERE WAS NO PATIENT CONSEQUENCE.

    Description of Event or Problem · 1

    A HOSPITAL IN GERMANY REPORTED THAT THERE WAS WATER LEAKAGE FROM THREE (B)(4) AUTOFEED HUMIDIFICATION CHAMBERS DURING USE WITH AN (B)(4) INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT. THE HOSPITAL HAS FURTHER REPORTED THAT THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290 110211

    Patients

    Seq Age Sex Outcome Treatment
    1 RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT| RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT