BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT REUSABLE HUMIDIFICATION CHAMBER

    MDR report key: 2182716 · Received July 28, 2011

    Report

    Report Number
    9611451-2011-00455
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Report Date
    July 1, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K913368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURE DATE: 12/14/2010 FOR LOT NUMBER 101214; 12/21/2010 FOR LOT NUMBER 101221. THE COMPLAINT MR370 CHAMBERS HAVE ONLY RECENTLY BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND ARE CURRENTLY BEING INVESTIGATED. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURE DATE: 12/14/2010 FOR LOT NUMBER 101214; 12/21/2010 FOR LOT NUMBER 101221. MANUFACTURER NARRATIVE METHOD: SEVEN MR370 ADULT REUSABLE CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INSPECTION. THE CHAMBERS WERE VISUALLY INSPECTED FOR CRACKS. RESULTS: VERTICAL CRACKS WERE FOUND AT THE BASE OF THE CHAMBER DOME. SOME CRACKS WERE ALSO FOUND AT THE UPPER PORTION OF THE DOME AND AT THE WATER INLET PORT. A LOT CHECK REVEALED TWO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 101214. A LOT CHECK REVEALED FOUR OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 101221. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE CRACKING, BUT IT IS LIKELY THAT THE CHAMBER HAS BEEN CLEANED WHILE THE ALUMINIUM BASE WAS STILL ATTACHED. IF THE BASE EXPANDED DUE TO HEAT DURING CLEANING IT COULD CREATE ENOUGH STRESS ON THE BASE OF THE DOME TO CAUSE IT TO CRACK. THE MR370 IS A REUSABLE CHAMBER. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR370 CHAMBER SPECIFY: "TO PREVENT CRACKING, ENSURE THAT THE WATER INLET PORT PLUG, AND ANY OTHER REUSABLE COMPONENTS, ARE DISCONNECTED FROM THE CHAMBER BEFORE CLEANING." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT SEVEN MR370 ADULT REUSABLE HUMIDIFICATION CHAMBERS HAD CRACKED FROM TOP TO BOTTOM. THIS WAS NOTICED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT SEVEN MR370 ADULT REUSABLE HUMIDIFICATION CHAMBERS HAD CRACKED FROM TOP TO BOTTOM AFTER ONE MONTH OF USE. THIS HAD OCCURRED WITH SEVEN OTHER CHAMBERS AS WELL. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT REUSABLE HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR370 101214 AND 101221

    Patients

    Seq Age Sex Outcome Treatment
    1