BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 3914495 · Received July 3, 2014

    Report

    Report Number
    9611451-2014-00590
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 5, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT IW933 COSYCOT INFANT WARMER WAS INSPECTED BY A TRAINED FPH SERVICE TECHNICIAN AT OUR SERVICE CENTRE IN (B)(4). RESULTS: DURING TESTING IT WAS NOTED THAT THE UNIT'S POWER FAIL ALARM DID NOT FUNCTION WHEN THE UNIT WAS DISCONNECTED FROM POWER. THE ROOT CAUSE WAS IDENTIFIED TO BE THE FAILURE OF A CAPACITOR ON THE PCB BOARD. THE UPPER HEAD CASE OF THE INFANT WARMER WAS ALSO OBSERVED AS BEING CRACKED. CONCLUSION: THE SUBJECT IW933 COSYCOT INFANT WARMER WAS RELEASED FOR DISTRIBUTION IN 2004. IT IS LIKELY THAT THE REPLACEABLE SUPER CAPACITOR ON THE PCB BOARD WORE OUT OVER TIME. 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 INCLUDING THE POWER FAIL ALARM 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 REPORTED MALFUNCTION WAS DISCOVERED DURING A MAINTENANCE CHECK WITH NO PATIENT INVOLVEMENT. WITH REGARDS TO THE CRACKED HEAD, IT IS LIKELY THAT THE CRACKING AND CRAZING OF THE COMPLAINT WARMER HEAD IS RELATED TO A KNOWN PROBLEM OF INCOMPATIBLE CLEANING SOLUTIONS REACTING WITH THE POLYCARBONATE PLASTIC AND ACRYLIC COMPONENTS OF THE INFANT WARMER. WHEN THE HEATER HEAD BEGINS TO WARM UP DURING USE, A CHEMICAL REACTION WITH THE INCOMPATIBLE CLEANING SOLUTION RESULTS IN GRADUAL CRACKING AND CRAZING OF THE HEATER HEAD. THE CRACKING COULD ALSO BE THE RESULT OF IMPACT DAMAGE AND WEAR AND TEAR WHILE MOVING THE WARMER BETWEEN WARDS. THE INFANT WARMER SERVICE MANUAL FEATURES A DIAGRAM OF THE INFANT WARMER WHICH HIGHLIGHTS POLYCARBONATE AND ACRYLIC COMPONENTS AND STATES THE FOLLOWING: CAUTION DO NOT CLEAN THE HIGHLIGHTED PLASTIC SURFACES WITH PROPRIETARY CLEANING PRODUCTS CONTAINING EITHER HYDROXIDES, HYPOCHLORITES, PEROXIDES, GLUTERALDEHYDE OR CLEANING PRODUCTS WITH A GREATER THAN 30% ALCOHOL BASE; CAUTION THE CHEMICALS USED IN THESE PROPRIETARY CLEANING PRODUCTS MAY LEAD TO DISCOLOURATION, CRAZING AND EVENTUAL CRACKING OF THE HIGHLIGHTED PLASTIC SURFACES. THE INFANT WARMER WAS REPAIRED AND A NEW CAPACITOR WAS FITTED TO THE PCB. THE SUBJECT INFANT WARMER WAS RETURNED TO THE CUSTOMER AFTER PASSING ALL THE NECESSARY SAFETY AND PERFORMANCE TESTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SERVICE REPORT RELATED TO THE COMPLAINT DEVICE HAS JUST BEEN RECEIVED AT FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A SERVICE CONTRACTOR REPORTED ON BEHALF OF A HOSPITAL IN (B)(6) THAT AN IW933 COSYCOT INFANT WARMER'S POWER FAIL ALARM DOES NOT WORK. THE UPPER CASE WAS ALSO OBSERVED AS BEING CRACKED.THIS WAS FOUND DURING SERVICING.

    Description of Event or Problem · 1

    A SERVICE CONTRACTOR REPORTED ON BEHALF OF A HOSPITAL IN (B)(6) THAT AN IW933 COSYCOT INFANT WARMER'S POWER FAIL ALARM DOES NOT WORK. THE UPPER CASE WAS ALSO OBSERVED AS BEING CRACKED. THIS WAS FOUND DURING SERVICING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390275 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW933 040622

    Patients

    Seq Age Sex Outcome Treatment
    1