BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 2232103 · Received September 1, 2011

    Report

    Report Number
    9611451-2011-00537
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 5, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE POWER PCB OF THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED POWER PCB OF THE COMPLAINT DEVICE WAS VISUALLY INSPECTED FOR DAMAGE AND WAS INSTALLED ON A WORKING UNIT FOR TESTING. RESULTS: VISUAL INSPECTION REVEALED THAT THE U17 CHIP OF THE POWER PCB WAS DAMAGED. THE BOARD DETAILS INDICATE THAT THE BOARD IS APPROXIMATELY SIX YEARS OLD. THE UNIT WAS UNABLE TO START UP DURING TESTING AS THE POWER FAIL ALARM AND "SEE MANUAL" LED DISPLAYED ONCE WHEN THE UNIT WAS POWERED ON. THE CONTROLLER OF THE TEST UNIT WAS NOT ABLE TO COMPLETE THE START UP SEQUENCE AND THE POWER PCB WAS CONFIRMED TO BE FAULTY. HOWEVER, THE POWER FAIL ALARM CIRCUITRY WAS ABLE TO FUNCTION NORMALLY WHEN THE MAINS ELECTRICAL POWER WAS REMOVED. CONCLUSION: THE FAULT WAS ISOLATED TO THE FAULTY U17 CHIP ON THE POWER PCB THAT PREVENTS THE CONTROLLER FROM STARTING UP. IT IS POSSIBLE THAT THE U17 CHIP WAS DAMAGED BY ELECTRICAL OVER-STRESS, WHICH MAY BE CAUSED BY AN APPLICATION OF EXTREME HIGH VOLTAGE WITH UNLIMITED CURRENT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR LOT 100525. A REPLACEMENT POWER PCB HAS BEEN PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE POWER FAIL ALARM ON AN IW934JEU COSYCOT INFANT WARMER WAS NOT WORKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE POWER FAIL ALARM ON AN IW934JEU COSYCOT INFANT WARMER WAS NOT WORKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW934 100525

    Patients

    Seq Age Sex Outcome Treatment
    1