BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 4797278 · Received May 27, 2015

    Report

    Report Number
    9611451-2015-00250
    Event Type
    Malfunction
    Date Received
    May 27, 2015
    Date of Event
    April 24, 2015
    Report Date
    April 27, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K073706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE IN THE PROCESS OF OBTAINING THE COMPLAINT DEVICE FOR EVALUATION. OUR INVESTIGATION IS IN PROGRESS AND WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR850 RESPIRATORY HUMIDIFIER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) IN (B)(4) FOR EVALUATION. THE RETURNED DEVICE WAS VISUALLY INSPECTED, PERFORMANCE TESTED AND THE EARTH BONDING TEST WAS ALSO CARRIED OUT. RESULTS: VISUAL INSPECTION REVEALED THAT THE REAR ENCLOSURE WAS CRACKED AND THAT THE POWER CORD LENGTH WAS DECREASED FROM 3.3M TO 0.6 M. THE POWER PLUG WAS ALSO MODIFIED AND A NON-FPH POWER PLUG WAS INSTALLED ON THE DEVICE. INSPECTION OF THE GROUNDING SCREW REVEALED MINOR DAMAGE TO THE SCREW HEAD AND GLUE WAS FOUND ON THE SCREWS AND BRASS BLOCK. THE SCREW CONNECTION WAS NOT LOOSE. THE PERFORMANCE TEST REVEALED NO FUNCTIONAL FAULT WITH THE RETURNED DEVICE. THE COMPLAINT DEVICE ALSO PASSED THE ELECTRICAL SAFETY AND EARTH CONTINUITY TEST. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 051027. CONCLUSION: NO FUNCTIONAL FAULT WAS FOUND WITH THE RETURNED MR850 RESPIRATORY HUMIDIFIER. THE MODIFIED POWER CORD AND PLUG SUGGESTS THAT THE DEVICE HAS UNDERGONE REPAIRS AT THE CUSTOMER FACILITY. FPH RECOMMENDS THAT ALL MR850 RESPIRATORY HUMIDIFIERS TO BE PERFORMANCE AND ELECTRICAL SAFETY TESTED DURING THE ANNUAL PREVENTATIVE MAINTENENACE CHECKS AS INDICATED IN THE MR850 PRODUCT TECHNICAL MANUAL. THE COMPLAINT DEVICE WAS MANUFACTURED IN OCTOBER 2005 AND IS ALMOST 10 YEARS OLD. IT IS LIKELY THAT THE RETURNED DEVICE HAS UNDERGONE MULTIPLE MAINTENANCE CHECKS AT THE CUSTOMER FACILITY. DURING PRODUCTION THE ELECTRICAL CONNECTIONS OF THE EARTH WIRES ON ALL MR850 UNITS ARE 100% TESTED FOR ELECTRICAL CONTINUITY. ANY PRODUCT THAT FAILS IS REJECTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE GROUNDING TERMINAL SCREWS ON THE POWER PCB OF AN MR850 HUMIDIFIER WERE LOOSE. THIS WAS FOUND DURING A PREVENTATIVE MAINTENANCE INSPECTION ON AN APPROXIMATELY 10 YEAR OLD DEVICE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE GROUNDING TERMINAL SCREWS ON THE POWER PCB OF AN MR850 HUMIDIFIER WERE LOOSE. THIS WAS FOUND DURING A PREVENTATIVE MAINTENANCE INSPECTION ON AN APPROXIMATELY 10 YEAR OLD DEVICE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343656 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR850 051027

    Patients

    Seq Age Sex Outcome Treatment
    1