BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 3780938 · Received April 30, 2014

    Report

    Report Number
    9611451-2014-00387
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    March 30, 2014
    Report Date
    March 31, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE CHAMBER DOME WAS CRACKED. A CRACK WAS OBSERVED BY THE HINGE BRACKET AND EXTENDS FROM THE FLANGE TO THE FEEDSET PORT. ANOTHER SMALL CRACK WAS OBSERVED APPROXIMATELY 4 MM FROM THE BASE WHICH PROPAGATES OFF THE FIRST CRACK. THERE WERE NO STRESS MARKS AROUND THE CRACK. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF A SIMILAR NATURE FOR LOT NUMBER 130911. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE DAMAGE. HOWEVER, IT IS KNOWN THAT PRESSURES PRODUCED IN EXCESS OF 80 CMH20 (8 KPA) MAY AFFECT THE INTEGRITY OF THE CHAMBER. EVERY MR290 CHAMBER IS PRESSURE TESTED TO 200 CMH2O 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. THE CUSTOMER REPORTED THAT THE SUBJECT CHAMBER WAS IN USE FOR SIX DAYS BEFORE THE LEAK WAS OBSERVED, WHICH INDICATES THAT THE CHAMBER BECAME DAMAGED DURING USE. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARMS." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "MAXIMUM OPERATING PRESSURE: 8 KPA."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER LEAKED AFTER SIX DAYS OF USE. THE HOSPITAL REPORTED THAT THIS HAD HAPPENED BEFORE WITH TWO ADDITIONAL MR290V CHAMBERS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER LEAKED AFTER SIX DAYS OF USE. THE HOSPITAL REPORTED THAT THIS HAD HAPPENED BEFORE WITH TWO ADDITIONAL MR290V CHAMBERS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260397 VENTED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 130911

    Patients

    Seq Age Sex Outcome Treatment
    1