BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 2341561 · Received November 17, 2011

    Report

    Report Number
    9611451-2011-00719
    Event Type
    Malfunction
    Date Received
    November 17, 2011
    Date of Event
    October 21, 2011
    Report Date
    October 21, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS EN ROUTE TO THE MANUFACTURER. WE WILL PROVIDE A FOLLOW UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE DEFECT WAS FOUND BY THE HOSPITAL BIOMED, WHO HAD ISOLATED THE PROBLEM TO THE INFANT WARMER'S TRANSFORMER. THE TRANSFORMER WAS RETURNED TO OUR (B)(4) FACILITY FOR INVESTIGATION AND THE RESISTANCE OF THE WINDINGS WAS MEASURED USING A DIGITAL MULTIMETER. RESULTS: THE RESISTANCE TESTING REVEALED THAT THE PRIMARY WINDING OF THE TRANSFORMER WAS OPEN CIRCUIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 060405. CONCLUSION: AN OPEN CIRCUIT OF THE PRIMARY WINDING OF THE TRANSFORMER WOULD PREVENT TRANSFER OF ELECTRICAL POWER TO THE CONTROLLER BOARDS. THE ABSENCE OF MAINS POWER TRIGGERS THE "POWER FAIL" ALARM. THUS THE CIRCUIT FUNCTIONED AS INTENDED. THE TRANSFORMER HAS A BUILT IN 130 DEGREE THERMAL CUT OUT PROTECTOR WHICH IS TRIGGERED BY HIGH TEMPERATURE. IT IS POSSIBLE THAT THE THERMAL CUT OUT TRIPPED DUE TO EXCESSIVE CURRENT. PART OF FISHER & PAYKEL HEALTHCARE'S QUALITY CONTROL PROCESS INVOLVES TESTING THE POWER FAILURE ALARM OF EVERY WARMER ON THE PRODUCTION LINE FOR FUNCTIONALITY PRIOR TO DISTRIBUTION. OUR REVIEW OF THE MANUFACTURING RECORDS FOR THIS COMPLAINT WARMER DID NOT REVEAL ANY DISCREPANCIES. THE DEVICE TECHNICAL/SERVICE MANUAL CONTAINS A CHECKLIST WHICH SPECIFIES THAT USERS PERFORM SAFETY, PERFORMANCE AND FUNCTIONAL CHECKS AT LEAST ONCE A YEAR.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE POWER FAIL ALARM ON AN IW934 COSYCOT INFANT WARMER WAS NOT WORKING. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) STATE REPORTED THAT THE POWER FAIL ALARM ON AN IW934 COSYCOT INFANT WARMER WAS NOT WORKING. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW934 060405

    Patients

    Seq Age Sex Outcome Treatment
    1