BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 1161414 · Received September 12, 2008

    Report

    Report Number
    9611451-2008-00531
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 14, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K913368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PS34498. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION. AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND PREVIOUS EXPERIENCE WITH SIMILAR COMPLAINTS. RESULTS: IT IS POSSIBLE THAT DURING THE REPORTED ABUSE TO THE BREATHING CIRCUIT (MANUFACTURED BY ANOTHER MANUFACTURER), THE HEATERWIRE IN THE BREATHING CIRCUIT WAS DAMAGED. CONCLUSION: IT IS NOT LIKELY TO BE THE RESPIRATORY HUMIDIFIER THAT MALFUNCTIONED IN THIS EVENT. APART FROM THE RESPIRATORY HUMIDIFIER, NO OTHER FISHER & PAYKEL HEALTHCARE DEVICES WERE REPORTED TO HAVE BEEN INVOLVED WITH THIS EVENT. WE ARE ATTEMPTING TO GAIN MORE INFORMATION REGARDING THIS COMPLAINT AND WILL PROVIDE A FOLLOW UP IF ANY INFORMATION IS FORTHCOMING. WE HAVE INFORMED THE MANUFACTURER OF THE BREATHING CIRCUIT OF THIS COMPLAINT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B) (4) REPORTED THAT AN ALLEGIANCE BREATHING CIRCUIT MELTED DURING USE WITH AN MR730 RESPIRATORY HUMIDIFIER. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR730

    Patients

    Seq Age Sex Outcome Treatment
    1 7100-452 ALLEGIANCE BREATHING CIRCUIT| BEARCUB 750 VENTILATOR