BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL COSYCOT INFANT WARMER

    MDR report key: 5728217 · Received June 15, 2016

    Report

    Report Number
    9611451-2016-00267
    Event Type
    Malfunction
    Date Received
    June 15, 2016
    Report Date
    May 19, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT INFANT WARMER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTER IN (B)(4). IT WAS VISUALLY INSPECTED, REPAIRED, PERFORMANCE CHECKED AND ELECTRICAL SAFETY TESTED, AS PER INFANT WARMER PRODUCT TECHNICAL MANUAL, BY A QUALIFIED FPH SERVICE ENGINEER. OUR ANALYSIS IS ACCORDINGLY BASED ON THE SERVICE REPORT PROVIDED BY FPH SERVICE ENGINEER AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE COMPLAINT INFANT WARMER. THE UNIT DISPLAYED AN ERROR CODE E17, WHICH WAS ATTRIBUTED TO FAULTY HEATING ELEMENT. THE POWER FAIL ALARM FUNCTIONED AS INTENDED DURING PERFORMANCE CHECKS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090629. CONCLUSION: NO FAULT WAS FOUND WITH THE POWER FAIL ALARM. THE FAULT REPORTED BY THE HOSPITAL WAS ISOLATED TO THE INFANT WARMER'S POWER SWITCH. THE SUBJECT INFANT WARMER WAS REPAIRED AND RETURNED TO THE HOSPITAL AFTER PASSING PERFORMANCE CHECKS AND ELECTRICAL SAFETY TESTS SPECIFIED IN THE INFANT WARMER PRODUCT TECHNICAL MANUAL. INSPECTED AT FPH US SERVICE CENTER.

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT IW934JEU BABY CONTROL COSYCOT INFANT WARMER FROM THE HOSPITAL. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE RECEIVED THE COMPLAINT DEVICE AND COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE POWER FAIL ALARM OF AN IW934JEU BABY CONTROL COSYCOT INFANT WARMER WAS NOT WORKING. IT WAS OBSERVED AFTER USE ON A PATIENT, WHEN THE POWER CORD OF THE SUBJECT INFANT WARMER WAS DISCONNECTED FROM THE MAIN POWER SUPPLY. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE POWER FAIL ALARM OF AN IW934JEU BABY CONTROL COSYCOT INFANT WARMER WAS NOT WORKING. IT WAS OBSERVED AFTER USE ON A PATIENT, WHEN THE POWER CORD OF THE SUBJECT INFANT WARMER WAS DISCONNECTED FROM THE MAIN POWER SUPPLY. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381226 BABY CONTROL COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW934JEU

    Patients

    Seq Age Sex Outcome Treatment
    1