BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL MOBILE INFANT WARMER

    MDR report key: 2618823 · Received June 17, 2012

    Report

    Report Number
    9611451-2012-00396
    Event Type
    Malfunction
    Date Received
    June 17, 2012
    Date of Event
    May 24, 2012
    Report Date
    May 24, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE DEFECTIVE WARMER HEAD ASSEMBLY OF THE IW910JEU BABY CONTROL MOBILE INFANT WARMER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTRE IN (B)(4). OUR ANALYSIS IS ACCORDINGLY BASED ON THE SERVICE REPORT AND PHOTOGRAPHS PROVIDED BY OUR SERVICE CENTRE. RESULTS: THERE WAS EVIDENCE OF CHIPPING OF THE PLASTIC SURFACE AT THE CORNER EDGES OF THE LOWER AND UPPER CASINGS. THE MIDDLE AREA OF THE UPPER CASE HAD CHIPPED OFF AS WELL. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 070208. CONCLUSION: IT IS MOST LIKELY THAT THE CHIPPING OBSERVED ON THE LOWER AND UPPER CASINGS IS RELATED TO IMPACT DAMAGE. THE IW910 INFANT WARMER IS A MOBILE UNIT THAT CAN BE MOVED FROM ONE LOCATION TO ANOTHER. IT IS POSSIBLE FOR THE WARMER HEAD ASSEMBLY TO INCUR ACCIDENTAL IMPACT DAMAGE THROUGH COLLISION WITH WALLS OR SWINGING DOORS DURING TRANSPORT AS THE WARMER HEAD CAN BE SWIVELLED BY ABOUT 130 DEGREES FROM ITS CENTRE POSITION. THE DEFECTIVE WARMER HEAD MOULDING HAS SINCE BEEN REPLACED AND RETURNED TO THE HOSPITAL AFTER IT PASSED THE ELECTRICAL SAFETY TEST.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT WARMER HEAD OF AN IW910JEU BABY CONTROL MOBILE INFANT WARMER HAD A CRACKED CASING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT WARMER HEAD OF AN IW910JEU BABY CONTROL MOBILE INFANT WARMER HAD A CRACKED CASING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1