BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROLLED MOBILE INFANT WARMER

    MDR report key: 1883666 · Received October 26, 2010

    Report

    Report Number
    9611451-2010-00643
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Report Date
    September 30, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE UPPER HARNESS AND HEATING ELEMENT OF THE COMPLAINT (B)(4) INFANT WARMER WERE RETURNED TO (B)(4) FOR INVESTIGATION. THE RETURNED COMPONENTS WERE VISUALLY INSPECTED FOR DAMAGE. THE ELECTRICAL RESISTANCE OF THE HEATING ELEMENT WAS TESTED USING A MULTIMETER. RESULTS: ONE OF THE TERMINALS, WHICH CONNECTS A WIRE TO THE HEATING ELEMENT, APPEARED BURNT. THE TAB, WHERE THE CONNECTOR IS INSERTED, SHOWED SOME SIGNS OF DAMAGE AND CORROSION. A PORTION OF THE WIRE INSULATION WAS MELTED. THERE WAS NO DAMAGE TO THE OTHER END OF THE HEATING ELEMENT, WHICH IS STILL INTACT AND CREATES A GOOD CONNECTION. THE RESISTANCE OF THE HEATING ELEMENT WAS FOUND TO BE WITHIN SPECIFICATIONS. CONCLUSION: THE TERMINAL CONNECTORS OF THE HEATING ELEMENT WERE FOUND TO BE DAMAGED. IT IS POSSIBLE THAT A LOOSE TERMINAL IN THE HEATING ELEMENT CAUSED INCREASED RESISTANCE DUE TO CORROSION BUILD UP, RESULTING TO A FAULTY CONNECTION. THE WARMER DISPLAYED AN ERROR CODE AND ENTERED A FAIL-SAFE STATE WHERE THE HEATER ELEMENT IS DISABLED AND THE INFANT WARMER ALARMS TO ALLOW THE USER TO ACT AND PROVIDE AN ALTERNATE MEANS OF WARMING. ALL COMPONENTS ON THE HARNESS ASSEMBLY OF THE INFANT WARMER ARE ENCLOSED IN A SHEATH AND FIRE RATED BY UNDERWRITERS LABORATORIES (UL).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT IW910JEU BABY CONTROLLED MOBILE INFANT WARMER IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6), REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN (B)(4) BABY CONTROLLED MOBILE INFANT WARMER "DOES NOT HEAT". THIS WAS NOTICED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN IW910JEU BABY CONTROLLED MOBILE INFANT WARMER "DOES NOT HEAT." THIS WAS NOTICED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BABY CONTROLLED MOBILE INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW910JEU

    Patients

    Seq Age Sex Outcome Treatment
    1