BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 2970786 · Received February 20, 2013

    Report

    Report Number
    9611451-2013-00132
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 24, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE ARE THUS UNABLE TO DETERMINE WHAT HAS CAUSED THE PROBLEM AS REPORTED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    (B)(4). FISHER & PAYKEL HEALTHCARE IS STILL ENDEAVOURING TO RETRIEVE THE COMPLAINT MR290 CHAMBER FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE WATER FEEDSET TUBE OF AN MR290V HUMIDIFICATION CHAMBER WAS DAMAGED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE WATER FEEDSET TUBE OF AN MR290V HUMIDIFICATION CHAMBER WAS DAMAGED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74966 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120829

    Patients

    Seq Age Sex Outcome Treatment
    1