BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2655552 · Received July 15, 2012

    Report

    Report Number
    9611451-2012-00458
    Event Type
    Malfunction
    Date Received
    July 15, 2012
    Report Date
    June 18, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBERS: 100409, 111129; MANUFACTURING DATES: 04/09/2010, 11/29/2011. THE COMPLAINT MR290HFV HIGH FREQUENCY VENTED AUTOFEED HUMIDIFICATION CHAMBERS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: 100409, 111129; MANUFACTURING DATE: 04/09/2010, 11/29/2011; (B)(4). METHOD: TWO COMPLAINT MR290HFV HIGH FREQUENCY VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) IN (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED FOR THE REPORTED LEAKS. RESULTS: VISUAL INSPECTION REVEALED THAT THE DOMES OF BOTH CHAMBERS WERE CRACKED AND THE ALUMINIUM BASES WERE DENTED. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THESE NATURES FOR BOTH LOT NUMBERS. CONCLUSION: IT IS MOST LIKELY THAT THE PHYSICAL DAMAGES TO THE RETURNED MR290HFV CHAMBERS WERE SUSTAINED DURING TRANSPORTATION OR STORAGE. EVERY MR290 CHAMBER IS PRESSURE TESTED TO (B)(4) 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 SUBJECT CHAMBERS WERE DAMAGED POST PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290 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 DISTRIBUTOR IN (B)(6) REPORTED THAT TWO MR290HFV HIGH FREQUENCY VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE LEAKING. THIS WAS NOTICED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED THAT TWO MR290HFV HIGH FREQUENCY VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE LEAKING. THIS WAS NOTICED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH FREQUENCY VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290HFV 100409 & 111129

    Patients

    Seq Age Sex Outcome Treatment
    1 RT202 ADULT HEATED INSPIRATORY CIRCUIT KIT| RT202 ADULT HEATED INSPIRATORY CIRCUIT KIT