BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL FEED ADULT HUMIDIFICATION CHAMBER

    MDR report key: 2800764 · Received October 22, 2012

    Report

    Report Number
    9611451-2012-00747
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Report Date
    September 24, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K913368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ATTEMPTING TO RETRIEVE THE COMPLAINT DEVICE. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE MANUFACTURER. ATTEMPTS TO RETRIEVE THE COMPLAINT DEVICE AND ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. WITHOUT THE RETURN OF THE COMPLAINT DEVICE OR DETAILED INFORMATION, WE ARE UNABLE TO CONFIRM OR DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM OBSERVED BY THE CUSTOMER. SHOULD WE RECEIVE THE COMPLAINT DEVICE OR FURTHER PERTINENT INFORMATION AT A LATER STAGE, WE WILL PROVIDE A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THREE MR250 CHAMBERS 'CRACKED ON THE PLASTIC MOLDING NEAR BASE' DURING USE. THE HOSPITAL HAS FURTHER REPORTED THAT TWO CHAMBERS HAVE BEEN DISPOSED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THREE MR250 CHAMBERS 'CRACKED ON THE PLASTIC MOLDING NEAR BASE' DURING USE. THE HOSPITAL HAS FURTHER REPORTED THAT TWO CHAMBERS HAVE BEEN DISPOSED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL FEED ADULT HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR250 111125

    Patients

    Seq Age Sex Outcome Treatment
    1