BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 1868612 · Received October 13, 2010

    Report

    Report Number
    9611451-2010-00624
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Report Date
    September 14, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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

    AS THE COMPLAINANT HAS ADVISED THAT THE COMPLAINT DEVICE WILL NOT BE RETURNED FOR INVESTIGATION, FISHER & PAYKEL HEALTHCARE HAS REQUESTED PHOTOGRAPHS FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE REQUESTED PHOTOGRAPHS AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: FISHER & PAYKEL HEALTHCARE REQUESTED PHOTOGRAPHS OF THE COMPLAINT DEVICE FOR INVESTIGATION, HOWEVER THE HOSPITAL HAS SINCE ADVISED THAT THE DEVICE WAS REPAIRED BEFORE PHOTOGRAPHS COULD BE TAKEN. AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND INFORMATION PROVIDED BY THE HOSPITAL. RESULTS: THE HOSPITAL REPORTED THAT THE "WHEELS AND THE PLEXIGLASS HEAD ARE DAMAGED." IN RELATION TO THE WHEEL, THE BIOMEDICAL ENGINEER REPORTED THAT IT APPEARED TO BE LOCKED. A SUBCONTRACTOR REPAIRED THE UNIT AND REPORTED THAT THE AXLE SYSTEM ON THE WHEEL HAD RUSTED, CONFIRMING THE REPORTED FAULT. IT WAS REPORTED THAT THE UNIT HAD BEEN STEAM CLEANED. THE HOSPITAL ADVISED THAT "PLEXIGLASS HEAD" REFERS TO THE FASCIA ON THE WARMER, WHICH IS WHERE THE CONTROL BUTTONS ARE LOCATED. A TECHNICIAN REPORTED THAT THE UNIT HAD FALLEN DURING CLEANING AND, AS A RESULT, THERE WERE CRACKS ON THE FASCIA. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 030807. CONCLUSION: ALTHOUGH THE DEVICE WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE, AN INVESTIGATION WAS CARRIED OUT BASED ON INFORMATION PROVIDED BY THE HOSPITAL. IT WAS OBSERVED THAT THE WHEEL HAD RUSTED. IT IS LIKELY THAT STEAM CLEANING HAD CAUSED OXIDATION OF THE AXLE. THE OPERATING MANUAL AND ACCESSORIES SERVICE MANUAL FOR THIS PRODUCT RECOMMEND REGULAR CHECKS AND MAINTENANCE OF THE BASE ASSEMBLY. THE FASCIA WAS REPORTED TO HAVE BEEN CRACKED DUE TO A FALL DURING THE CLEANING PROCESS. REPLACEMENT PARTS HAVE BEEN SUPPLIED TO THE CUSTOMER AND THE DEVICE HAS BEEN REPAIRED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN IW930 COSYCOT INFANT WARMER WAS DAMAGED. IT WAS REPORTED THAT THE WHEELS SEEM TO BE LOCKED AND THE FASCIA IS DAMAGED. IT WAS ALSO REPORTED THAT THE WARMER HEAD WAS BROKEN DURING CLEANING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN IW930 COSYCOT INFANT WARMER WAS DAMAGED. IT WAS REPORTED THAT THE WHEELS SEEM TO BE LOCKED AND THE FASCIA IS DAMAGED. IT WAS ALSO REPORTED THAT THE WARMER HEAD WAS BROKEN DURING CLEANING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW930AFU 030807

    Patients

    Seq Age Sex Outcome Treatment
    1