BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL COSYCOT INFANT WARMER

    MDR report key: 3151045 · Received June 6, 2013

    Report

    Report Number
    9611451-2013-00446
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 9, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPONENT OF THE COMPLAINT IW980JEU BABY CONTROL COSYCOT INFANT WARMER IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4) METHOD: THE CONTROLLER ASSEMBLY OF THE COMPLAINT IW980JEU BABY CONTROL COSYCOT INFANT WARMER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTRE IN (B)(4), WHERE IT WAS REPAIRED BY A TRAINED FPH SERVICE ENGINEER. THE DEFECTIVE POWER PCB BOARD AND THE LOWER HARNESS WERE RETURNED TO FPH IN (B)(4) FOR INSPECTION. THE POWER PCB BOARD WAS PERFORMANCE TESTED BY INSERTING IT INTO A WORKING INFANT WARMER UNIT. OUR ANALYSIS IS ACCORDINGLY BASED ON THE SERVICE REPORT PROVIDED BY FPH SERVICE CENTRE AND THE PERFORMANCE TEST RESULT OF THE RETURNED POWER PCB BOARD. RESULTS: WHEN POWER WAS APPLIED, THE TEST INFANT WARMER POWERED UP AND WORKED NORMALLY. THE REPORTED PROBLEM WITH THE DISPLAY ON THE CONTROL PANEL WAS NOT REPLICATED DURING THE PERFORMANCE CHECK; HOWEVER, THE POWER FAIL ALARM DID NOT OPERATE WHEN THE POWER AT THE SUPPLY WALL OUTLET WAS SWITCHED OFF. CONTINUITY TESTING OF THE SUPERCAPACITOR ON THE POWER PCB BOARD SHOWED THAT THE TRACK CONNECTION WAS OPEN BETWEEN THE TOP AND THE BOTTOM PARTS OF THE SOLDERING PAD. THE SERVICE REPORT STATED THAT THE FASCIA OF THE CONTROLLER ASSEMBLY WAS PEELING OFF AND THE EDGES OF THE CONTROL PANEL WERE CHIPPING OFF. THE FERRITE CORE OF THE LOWER HARNESS WAS ALSO MISSING. A LOT CHECK REVEALED NO OTHER COMPLAINT RELATED TO POWER PCB BOARD WAS RECEIVED FOR LOT NUMBER 031031; HOWEVER, IT SHOWED THAT WE RECEIVED ONE OTHER COMPLAINT RELATED TO DAMAGED FASCIA. CONCLUSION: THE SUBJECT INFANT WARMER UNIT WAS NEARLY 10 YEARS OLD AT THE TIME OF INSPECTION AT THE HOSPITAL FACILITY. THE SUPERCAPACITOR OF THE POWER PCB BOARD, WHICH IS A REPLACEABLE COMPONENT, STORES SUFFICIENT ELECTRICAL CHARGE TO POWER THE INFANT WARMER'S VISUAL AND AUDIBLE ALARMS IN THE EVENT OF THE MAINS POWER FAILURE. DURING INSPECTION, IT WAS OBSERVED THAT THERE WAS AN OPEN CIRCUIT IN THE CONNECTION OF THE SUPERCAPACITOR, PREVENTING IT FROM WORKING. IT IS MOST LIKELY THAT THE CONNECTION WAS DAMAGED WHEN THE OLD SUPERCAPACITOR WAS REPLACED AT THE HOSPITAL FACILITY, MAKING THE POWER FAIL ALARM INOPERABLE WHEN THE NEW SUPERCAPACITOR WAS FITTED. IT IS LIKELY THAT THE PEELING AND CHIPPING OBSERVED ON THE FASCIA ARE RELATED TO A KNOWN PROBLEM OF INCOMPATIBLE CLEANING SOLUTIONS REACTING WITH THE POLYCARBONATE PLASTIC AND ACRYLIC COMPONENTS OF THE INFANT WARMER. THE CHEMICAL REACTION WITH THE INCOMPATIBLE CLEANING SOLUTION RESULTS IN GRADUAL CRAZING AND PEELING OF THE FASCIA THE INFANT WARMER SERVICE MANUAL FOR THE AFFECTED UNIT 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, GLUTARALDEHYDE 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." WE HAVE SINCE REVISED OUR CLEANING INSTRUCTIONS TO RECOMMEND SPECIFIC PROPRIETARY CLEANING WIPES. THE DEFECTIVE CONTROLLER ASSEMBLY HAS SINCE BEEN REPAIRED AND RETURNED TO THE HOSPITAL AFTER IT PASSED THE REQUIRED PERFORMANCE CHECKS AND ELECTRICAL SAFETY TESTS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE POWER FAIL ALARM OF AN IW980JEU BABY CONTROL COSYCOT INFANT WARMER WAS NOT WORKING AND THE DISPLAY ON THE CONTROL PANEL WAS NOT LIGHTING UP. THIS WAS OBSERVED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN(B)(6) REPORTED THAT THE POWER FAIL ALARM OF AN IW980JEU BABY CONTROL COSYCOT INFANT WARMER WAS NOT WORKING AND THE DISPLAY ON THE CONTROL PANEL WAS NOT LIGHTING UP. THIS WAS OBSERVED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250520 BABY CONTROL COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW980JEU 031031

    Patients

    Seq Age Sex Outcome Treatment
    1