BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 5252563 · Received November 26, 2015

    Report

    Report Number
    9611451-2015-00503
    Event Type
    Malfunction
    Date Received
    November 26, 2015
    Date of Event
    October 28, 2015
    Report Date
    October 28, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K073706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT SPARE PCB ASSEMBLY WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(6) FOR INVESTIGATION. IT WAS VISUALLY INSPECTED AND THE COIL RESISTANCE OF THE BUZZER WAS MEASURED. RESULTS: VISUAL INSPECTION REVEALED NO SIGNS OF IMPACT DAMAGE. THE COIL RESISTANCE OF THE BUZZER ON THE RETURNED SPARE PCB ASSEMBLY WAS NOTED TO BE GREATER THAN THE RESISTANCE OF A WORKING BUZZER. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 150915. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE DAMAGE OBSERVED ON THE BUZZER OF THE RETURNED SPARE PCB ASSEMBLY. ALL SPARE PCB ASSEMBLIES UNDERGO AN OPERATOR ASSISTED TEST FOR THE FUNCTION OF THE BUZZER PRIOR TO BEING RELEASED FOR DISTRIBUTION. THIS SUGGESTS THE REPORTED DAMAGE OCCURED AFTER THE SPARE PCB ASSEMBLY WAS RELEASED FOR DISTRIBUTION. OUR MR850 PRODUCT TECHNICAL MANUAL CONTAINS A MAINTENANCE SCHEDULE WHICH INSTRUCTS THE USER TO CONDUCT ANNUAL VISUAL CHECKING AND PERFORMANCE TESTING OF THE MR850 HEATER BASE. IN ADDITION THE PRODUCT TECHNICAL MANUAL ALSO STATES THAT "ALL SERVICING PROCEDURES SHOULD BE FOLLOWED BY A HUMIDIFIER TEST, AND AN ELECTRICAL SAFETY TEST TO ENSURE PROPER OPERATION". THE MR850 IS EQUIPPED WITH VISUAL ALARM INDICATORS IN ADDITION TO THE AUDIBLE ALARM.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER FROM A HEALTHCARE FACILITY IN (B)(6), REPORTED THAT AN MR850 RESPIRATORY HUMIDIFIER'S SPARE PCB ASSEMBLY WAS NOT MAKING ANY NOISE UPON INSTALLING THE PCB INTO THE HUMIDIFIER. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782513 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR850 150915

    Patients

    Seq Age Sex Outcome Treatment
    1