BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL MOBILE INFANT WARMER

    MDR report key: 3046253 · Received April 10, 2013

    Report

    Report Number
    9611451-2013-00256
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 15, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SERIAL NUMBER: (B)(4), QUANTITY AFFECTED: 1, MANUFACTURING DATE: 06/29/2005; (B)(4), 1, 06/29/2005; (B)(4), 1, 09/14/2007. THE DISCOLOURED HEAD HARNESS CONNECTORS WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INSPECTION. WITHOUT THE COMPLAINT HARNESS CONNECTORS, WE WERE UNABLE TO CONFIRM THE REPORTED FAULT. IT SHOULD BE NOTED THAT THE SUBJECT INFANT WARMERS ARE AROUND SIX TO EIGHT YEARS OLD. THE UPPER AND LOWER HEAD HARNESSES ARE USED TO CONNECT THE HEAD UNIT TO THE CONTROL UNIT OF THE INFANT WARMER. BASED ON THE RESULTS OF OUR PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS, THE DISCOLOURATION OF THE HOUSING CONNECTOR IS MOST LIKELY DUE TO CONTACT FAILURE. THE CONTACT FAILURE IS MOST LIKELY DUE TO POOR CONNECTION, CAUSED BY CONSTANT SWIVELLING OF THE HEATER HEAD. 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 FAIL DURING USE, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). SERIAL NUMBER: (B)(4), (B)(4), (B)(4); QUANTITY AFFECTED: (B)(4), (B)(4), (B)(4); MANUFACTURING DATE: 06/29/2005, 06/29/2005, 09/14/2007. WE ARE STILL IN THE PROCESS OF OBTAINING THE REPORTED DISCOLOURED HARNESS CONNECTORS FROM THE HOSPITAL. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE RECEIVED THE COMPLAINT CONNECTORS AND COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE HEAD HARNESS CONNECTORS OF THREE IW910JEU BABY CONTROL MOBILE INFANT WARMERS WERE DISCOLOURED. THIS WAS OBSERVED DURING INSPECTION CONDUCTED BY THE BIOMED OF THE HOSPITAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE HEAD HARNESS CONNECTORS OF THREE IW910JEU BABY CONTROL MOBILE INFANT WARMERS WERE DISCOLOURED. THIS WAS OBSERVED DURING INSPECTION CONDUCTED BY THE BIOMED OF THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150649 BABY CONTROL MOBILE INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW910JEU

    Patients

    Seq Age Sex Outcome Treatment
    1