BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT WARMER HEATER ASSEMBLY

    MDR report key: 2042776 · Received April 6, 2011

    Report

    Report Number
    9611451-2011-00221
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 10, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K970432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT IW900 INFANT WARMER HEAD ASSEMBLY 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.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT HEAD ASSEMBLY OF THE INFANT WARMER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) IN (B)(4) FOR INSPECTION. AN ATTEMPT WAS MADE TO OBTAIN THE AFFECTED HEAD ASSEMBLY BUT THE CUSTOMER SERVICE REPRESENTATIVE FROM THE HEALTHCARE FACILITY COULD NOT LOCATE IT. OUR ANALYSIS IS ACCORDINGLY BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, REVIEW OF DESIGN HISTORY RECORD (DHR) OF THE COMPLAINT DEVICE AND RESULTS OF PREVIOUS INVESTIGATION ON SIMILAR COMPLAINTS. RESULTS: THE DHR REVIEW SHOWED THAT THE SUBJECT HEATER ASSEMBLY PASSED THE ELECTRICAL SAFETY CHECK AND FUNCTIONAL TEST DURING PRODUCTION. IT ALSO PASSED THE QUALITY CONTROL INSPECTION CHECK. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110211. CONCLUSIONS: ALL COMPONENTS OF THE INFANT WARMER UNITS ARE VISUALLY INSPECTED PRIOR TO DISTRIBUTION. ANY COMPONENT WHICH DOES NOT PASS THE VISUAL INSPECTION IS DISCARDED. THIS SUGGESTS THE CERAMIC INSULATOR OF THE HEAD ASSEMBLY WAS DAMAGED POST PRODUCTION, POSSIBLY DURING TRANSIT. A REPLACEMENT PART HAS SINCE BEEN SENT TO THE HEALTHCARE FACILITY. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT AN IW900 INFANT WARMER HEAD ASSEMBLY WAS BROKEN INTERNALLY. THE CERAMIC PIECES, THAT USED TO HOLD THE HEATING ELEMENT, "ARE BROKEN AND ARE FLOATING INTERNALLY". THIS WAS OBSERVED BEFORE USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    (B)(6) MEDICAL REPORTED THAT AN IW900 INFANT WARMER HEAD ASSEMBLY WAS BROKEN INTERNALLY. THE CERAMIC PIECES, THAT USED TO HOLD THE HEATING ELEMENT, "ARE BROKEN AND ARE FLOATING INTERNALLY". THIS WAS OBSERVED BEFORE USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT WARMER HEATER ASSEMBLY FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED 043041130 110211

    Patients

    Seq Age Sex Outcome Treatment
    1