BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 6028861 · Received October 13, 2016

    Report

    Report Number
    9611451-2016-00658
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Report Date
    August 16, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K073706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE MR850 RESPIRATORY HUMIDIFIER IS A REPAIRABLE DEVICE, ONLY THE AFFECTED COMPLAINT SPARE PCB ASSEMBLY (LOT 160602, MANUFACTURED ON 2 JUNE 2016) WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION, WHERE IT WAS VISUALLY INSPECTED AND PERFORMANCE TESTED. RESULTS: VISUAL INSPECTION REVEALED NO SIGNS OF IMPACT DAMAGE. INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE AUDIBLE ALARM COULD NOT BE HEARD. IT IS LIKELY THAT A POOR ELECTRICAL CONNECTION BETWEEN THE EPROM AND SOCKET PINS LEAD TO THE REPORTED EVENT. THE EPROM WAS REFITTED IN ITS SOKET AND THE UNIT WAS FULLY FUNCTIONAL. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 160602. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE POOR ELECTRICAL CONNECTION OBSERVED ON THE RETURNED SPARE PCB ASSEMBLY. ALL SPARE PCB ASSEMBLIES UNDERGO AN OPERATOR ASSISTED TEST FOR THE FUNCTION OF THE PCB BEFORE 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

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE MR850 RESPIRATORY HUMIDIFIER WITH A SPARE PCB ASSEMBLY WAS NOT MAKING ANY NOISE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678737 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR850

    Patients

    Seq Age Sex Outcome Treatment
    1