BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL COSYCOT INFANT WARMER

    MDR report key: 6052934 · Received October 24, 2016

    Report

    Report Number
    9611451-2016-00693
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    July 11, 2016
    Report Date
    July 11, 2016
    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 ELECTRICAL COMPONENTS AND CONTROL PANEL OF THE COMPLAINT IW930JEU BABY CONTROL COSYCOT INFANT WARMER WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTER IN (B)(4) AND INSPECTED BY A TRAINED FPH SERVICE ENGINEER. THE FAULTY POWER PCB BOARD WAS SUBSEQUENTLY RETURNED TO FPH IN (B)(4) FOR FURTHER INVESTIGATION. OUR ANALYSIS IS ACCORDINGLY BASED ON THE SERVICE REPORT PROVIDED BY FPH SERVICE ENGINEER AND THE RESULTS OF THE INVESTIGATION CONDUCTED IN (B)(4). RESULTS: DURING SERVICING AT FPH SERVICE CENTER, THE LOW TEMPERATURE AND THE CHECK BABY ALARMS WERE NOT REPLICATED; HOWEVER, IT WAS OBSERVED THAT THE POWER FAIL ALARM WAS NOT FUNCTIONING DUE TO FAULTY POWER PCB BOARD. FURTHER INVESTIGATION CONDUCTED AT FPH (B)(4) CONFIRMED THE NON-FUNCTIONING POWER FAIL ALARM, WHICH WAS ATTRIBUTED TO SUPER CAPACITOR FAILURE ON THE POWER PCB BOARD. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 030113. CONCLUSION: THE SUBJECT INFANT WARMER UNIT IS MORE THAN 13 YEARS OLD AND IT IS LIKELY THAT THE REPLACEABLE SUPER CAPACITOR ON THE PCB BOARD HAD SIMPLY WORN OUT. THE SUPER CAPACITOR'S FUNCTION IS TO STORE SUFFICIENT ELECTRICAL CHARGE TO POWER THE WARMER'S VISUAL AND AUDIBLE ALARMS IN THE EVENT OF A FAILURE OF MAINS POWER. 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. THE DEVICE TECHNICAL/SERVICE MANUAL CONTAINS A CHECKLIST WHICH SPECIFIES THAT USERS PERFORM SAFETY, PERFORMANCE AND FUNCTIONAL CHECKS AT LEAST ONCE A YEAR. INCLUDED IN THE WARMER'S MAINTENANCE CHECKLIST IS A TEST OF THE SUPER CAPACITOR TO ENSURE IT IS OPERATING WITHIN SPECIFICATIONS. THE POWER PCB BOARD ON THE CONTROL PANEL WAS REPLACED AND WAS RETURNED TO THE HOSPITAL SERVICE AFTER PASSING THE PERFORMANCE CHECKS AND ELECTRICAL SAFETY TESTS SPECIFIED IN THE PRODUCT TECHNICAL MANUAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN IW930JEU BABY CONTROL COSYCOT INFANT WARMER DISPLAYED A LOW TEMPERATURE AND A CHECK BABY ALARMS. NO PATIENT CONSEQUENCE WAS REPORTED. THE HOSPITAL ALSO REQUESTED TO SERVICE THE SUBJECT INFANT WARMER UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702207 BABY CONTROL COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW930JEU

    Patients

    Seq Age Sex Outcome Treatment
    1