BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 1668632 · Received April 21, 2010

    Report

    Report Number
    9611451-2010-00240
    Event Type
    Malfunction
    Date Received
    April 21, 2010
    Report Date
    March 30, 2010
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT INFANT WARMER WAS NOT AVAILABLE FOR EVALUATION, HOWEVER, THE HOSPITAL PROVIDED PHOTOGRAPHS OF THE COMPLAINT DEVICE. AN INVESTIGATION WAS CONDUCTED BASED ON INFORMATION PROVIDED BY THE CUSTOMER AND PHOTOGRAPHS OF THE COMPLAINT DEVICE. RESULTS: PHOTOGRAPHS PROVIDED BY THE HOSPITAL SHOWED THAT ONE OF THE CONTROL BUTTONS ON THE INFANT WARMER FASCIA HAS PEELED OFF AND THE EXTRUSION THAT ACTIVATES THE TACK SWITCH HAD ALSO BROKEN AWAY. THERE IS ALSO EVIDENCE OF CRAZING ON THE OTHER CONTROL BUTTONS ON THE PANEL. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 040129. CONCLUSION: THE IW930 INFANT WARMER CAN BE USED IN BABY MODE OR MANUAL MODE. THE MODES ARE SELECTED BY PRESSING THE BABY MODE (AUTOMATIC) OR MANUAL MODE BUTTON ON THE CONTROL PANEL. THE BABY MODE BUTTON WAS FOUND TO HAVE PEELED OFF OF THE CONTROL PANEL OF THE COMPLAINT INFANT WARMER. THE HOSPITAL REPORTED THAT THEY WERE CLEANING THE UNIT REGULARLY USING BACTINYL SPRAY. BACTINYL CONTAINS QUATERNARY AMMONIUM. THE CAUSE OF CRAZING OF AN INFANT WARMER IS LIKELY TO BE A KNOWN PROBLEM OF INCOMPATIBLE CLEANING SOLUTIONS. FPH'S INFANT WARMER CLEANING INSTRUCTIONS HAVE ALWAYS CONTAINED INFORMATION REGARDING APPROPRIATE CLEANING SOLUTIONS AND IDENTIFIED CHEMICALS TO AVOID SUCH AS AROMATIC HYDROCARBONS, AMMONIA, AMINES, AND AQUEOUS ALKALINE SOLUTIONS. AS PART OF A CONTINUOUS IMPROVEMENT, WE HAVE SINCE REVISED OUR INFANT WARMER CLEANING INSTRUCTIONS RECOMMENDING SPECIFIC PROPRIETARY CLEANING WIPES THAT CAN BE USED AND SEPARATELY HIGHLIGHTED VIA DIAGRAMS AREAS ON THE WARMER WHERE POLYCARBONATE PLASTIC IS FOUND.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE BABY KEY ON AN IW930 COSYCOT INFANT WARMER IS FAULTY. IT WAS REPORTED THAT THE BUTTON WAS DAMAGED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSYCOT INFANT WARMER FMT FISHER & PAYKEL HEALTHCARE LTD. IW930AFU 040129

    Patients

    Seq Age Sex Outcome Treatment
    1