BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2893913 · Received January 2, 2013

    Report

    Report Number
    9611451-2013-00006
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    November 22, 2012
    Report Date
    December 7, 2012
    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 MR290 CHAMBER IS CURRENTLY IN TRANSIT TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE COMPLAINT DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE COMPLAINT CHAMBER DOME WAS CRACKED AT THE BAFFLE. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 100620. CONCLUSION: WE WERE UNABLE TO DETERMINE THE ROOT CAUSE, ALTHOUGH IT IS KNOWN THAT PRESSURES PRODUCED IN EXCESS OF 80 CMH20 MAY AFFECT THE INTEGRITY OF THE CHAMBER. EVERY MR290 CHAMBER IS PRESSURE TESTED TO 8KPA (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. THE CUSTOMER HAS REPORTED THAT THE CRACK APPEARED AFTER 1 TO 2 DAYS OF USE, INDICATING THE FAULT OCCURRED POST PRODUCTION. 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." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS CRACKED AT THE DOME AFTER 1-2 DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS CRACKED AT THE DOME AFTER 1-2 DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 100620

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening