BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT HUMIDIFICATION CHAMBER

    MDR report key: 3433681 · Received October 28, 2013

    Report

    Report Number
    9611451-2013-00849
    Event Type
    Malfunction
    Date Received
    October 28, 2013
    Date of Event
    September 30, 2013
    Report Date
    October 3, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR210 ADULT HUMIDIFICATION CHAMBERS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE FOUR COMPLAINT MR210 ADULT HUMIDIFICATION CHAMBERS WERE RETURNED TO FPH IN (B)(4) AND WERE VISUALLY INSPECTED FOR CRACKS. RESULTS: VISUAL INSPECTED REVEALED THAT ALL FOUR CHAMBERS WERE CRACKED AT THE TOP OF THE CHAMBER DOME, NEAR ONE OF THE PORTS. DENTS WERE ALSO FOUND ON THE BASE OF ONE OF THE CHAMBERS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130507. CONCLUSION: BASED ON THE RESULTS OF OUR INVESTIGATION, THE CRACKING APPEARS TO HAVE BEEN CAUSED BY SOME FORM OF IMPACT TO THE CHAMBERS. THIS COULD HAVE OCCURRED EITHER DURING TRANSPORT TO, OR HANDLING OR STORAGE, AT THE CUSTOMER FACILITY. EVERY MR210 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS EITHER OF THESE TESTS IS REJECTED. THE DAMAGE WOULD THEREFORE HAVE OCCURRED AFTER THE CHAMBERS WERE RELEASED FOR DISTRIBUTION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE DOMES OF FOUR MR210 ADULT HUMIDIFICATION CHAMBERS WERE CRACKED WHEN THE PACKAGING WAS OPENED. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE DOMES OF FOUR MR210 ADULT HUMIDIFICATION CHAMBERS WERE CRACKED WHEN THE PACKAGING WAS OPENED. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550864 ADULT HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR210 130507

    Patients

    Seq Age Sex Outcome Treatment
    1