BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL CONTROLLED INFANT WARMER

    MDR report key: 4696006 · Received April 15, 2015

    Report

    Report Number
    9611451-2015-00199
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Report Date
    March 17, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE IN THE PROCESS OF GATHERING FURTHER INFORMATION FROM THE HOSPITAL REGARDING THE REPORTED PROBLEM. OUR INVESTIGATION IS CURRENTLY IN PROGRESS AND WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT DEVICE WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) IN (B)(4) FOR EVALUATION. THEREFORE, OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL, PREVIOUS SIMILAR INVESTIGATIONS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE CUSTOMER REPORTED THAT THE PIVOT SECURING NUT WAS LOOSE WHEN THE DEVICE WAS INSPECTED BY THE HOSPITAL TECHNICIAN. THEY FURTHER REPORTED THAT THE COMPLAINT DEVICE WAS PERFORMANCE CHECKED IN JANUARY 2015 WITH NO ISSUES REGARDING THE PIVOT SECURING NUT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 051013. CONCLUSION: THE TECHNICAL MANUAL SUPPLIED WITH THE IW990 MANUAL CONTROLLED INFANT WARMER RECOMMENDS SAFETY, PERFORMANCE AND FUNCTIONAL CHECKS TO BE CONDUCTED ON THE INFANT WARMER AT LEAST ANNUALLY. THIS INCLUDES A FUNCTIONAL CHECK OF THE WARMER'S HEATER HEAD TO ENSURE THAT IT IS SECURE, CAN BE ROTATED SMOOTHLY AND THAT THE CENTRAL DETENTE CAN BE FELT WHEN ROTATING. THE TECHNICAL MANUAL FURTHER INFORMS THE USER THAT THE PIVOT NUT CAN BE ADJUSTED OR REPLACED IF NECESSARY. IT IS UNLIKELY THAT THE PIVOT SECURING NUT BECAME LOOSE SINCE THE PERFORMANCE CHECK IN JANUARY. A LOOSE NUT SHOULD HAVE BEEN IDENTIFIED DURING THE SAFETY, PERFORMANCE AND FUNCTIONAL CHECKS. SINCE THE REPORTED EVENT AN FPH REPRESENTATIVE HAS BEEN IN CONTACT WITH THE CUSTOMER AND HAS PROVIDED ADDITIONAL INFORMATION ON TIGHTENING THE PIVOT SECURING NUT. IN ADDITION, WE ARE IN THE PROCESS OF SCHEDULING ADDITIONAL TRAINING WITH THE CUSTOMER ON THE CORRECT PERFORMANCE CHECK OF THE INFANT WARMER'S HEATER HEAD.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE PIVOT SCREWING NUT ON AN IW990 MANUAL CONTROLLED INFANT WARMER WAS LOOSE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED THAT THE PIVOT SCREWING NUT ON AN IW990 MANUAL CONTROLLED INFANT WARMER WAS LOOSE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250610 MANUAL CONTROLLED INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW990 051013

    Patients

    Seq Age Sex Outcome Treatment
    1