BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 4317768 · Received December 10, 2014

    Report

    Report Number
    9611451-2014-00913
    Event Type
    Malfunction
    Date Received
    December 10, 2014
    Date of Event
    October 29, 2014
    Report Date
    November 18, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K953392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT HC500 HUMIDIFIER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE HC500 WAS VISUALLY INSPECTED AND PERFORMANCE TESTED. RESULTS: THE COMPLAINT DEVICE WAS TESTED BY CAUSING AN AUDIBLE ALARM TO OCCUR. THE ALARM WAS FAINT, HOWEVER ALL VISUAL ALARMS FUNCTIONED PROPERLY. VISUAL INSPECTION REVEALED THAT THE SPEAKER WAS BROKEN AS A RESULT OF PHYSICAL DAMAGE. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR LOT NUMBER 090515. CONCLUSION: BASED ON THE APPEARANCE OF THE OBSERVED DAMAGE TO THE SPEAKER IT APPEARS LIKELY THAT THE DAMAGE WAS CAUSED BY SOME FORM OF PHYSICAL IMPACT. OUR HC500 PRODUCT TECHNICAL MANUAL CONTAINS A MAINTENANCE SCHEDULE WHICH INSTRUCTS THE USER TO CONDUCT ANNUAL VISUAL CHECKING AND PERFORMANCE TESTING OF THE HC500 HUMIDIFIER. IN ADDITION THE OPERATING MANUAL ADVISES THAT "IN THE EVENT THAT AN ALARM CODE IS DISPLAYED, THE HC500 WILL REQUIRE SERVICE. PLEASE TAKE A NOTE OF THE CODE AND ADVISE THE TECHNICIAN." THE COMPLAINT DEVICE HAS SINCE BEEN REPAIRED AND RETURNED TO SERVICE AT THE HOSPITAL AFTER PASSING ALL PERFORMANCE CHECKS.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT A HC500 HUMIDIFIER HAD A FAINT ALARM. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798775 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LTD HC500 090515

    Patients

    Seq Age Sex Outcome Treatment
    1