BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALL MOUNT INFANT WARMER

    MDR report key: 3920955 · Received July 9, 2014

    Report

    Report Number
    9611451-2014-00568
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 12, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).METHOD: THE SUBJECT INFANT WARMER HOUSING CONNECTORS WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4). OUR INVESTIGATION IS THEREFORE BASED ON OUR KNOWLEDGE OF THE PRODUCT AND PHOTOGRAPHS PROVIDED BY THE CUSTOMER.RESULTS: THE PHOTOGRAPH OF ONE OF THE HOUSING CONNECTORS SHOWED A BURNT SECTION WHERE THE WIRE TERMINAL IS LOCATED AND THE BLUE WIRE WAS DISCONNECTED FROM THE CONNECTOR. THE PHOTOGRAPH OF THE SECOND HOUSING CONNECTOR SHOWED SLIGHT DISCOLOURATION IN THE SAME LOCATION. THE THIRD COMPLAINT RELATED TO A HOUSING CONNECTOR WITH NO DISCOLOURATION OR ISSUES BUT A PREVENTIVE REPLACEMENT WAS REQUESTED.A LOT CHECK OF LOT NUMBER 031117 REVELAED NO OTHER SIMILAR COMPLAINTS.CONCLUSION: THE UPPER AND LOWER HARNESSES ARE USED TO CONNECT THE HEATER HEAD TO THE CONTROL UNIT OF THE INFANT WARMER. THE DISCOLOURED HOUSING CONNECTORS WERE MOST LIKELY DUE TO FREQUENT HEAD SWIVELLING WHICH PUTS STRESS ON THE CONNECTOR JOINT AND DISTURBS THE TERMINAL CONTACTS, CAUSING OVERHEATING AND DISCOLOURATION OF THE CONNECTOR HOUSING.ALL COMPONENTS ON THE HARNESS ASSEMBLY OF THE INFANT WARMER ARE ENCLOSED IN A SHEATH AND FIRE RATED BY UNDERWRITERS LABORATORIES (UL). SHOULD THE CONNECTORS COMPLETELY FAIL DURING THE OPERATION, AN AUDIBLE AND VISUAL ALARM WILL BE REGISTERED ON THE FRONT CONTROL PANEL OF THE INFANT WARMER, THEREBY ALLOWING THE HOSPITAL STAFF TIME TO ACT AND PROVIDE OTHER MEANS OF WARMING.THE INFANT WARMERS WERE SEVICED BY THE BIOMEDICAL ENGINEER AT THE HOSPITAL IN ACCORDANCE WITH OUR INFANT WARMER TECHNICAL MANUAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THREE IW980 WALL MOUNT INFANT WARMERS HAD BURNT HARNESSES.NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402061 WALL MOUNT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW980 031117

    Patients

    Seq Age Sex Outcome Treatment
    1