BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 5382699 · Received January 21, 2016

    Report

    Report Number
    9611451-2016-00021
    Event Type
    Malfunction
    Date Received
    January 21, 2016
    Report Date
    December 22, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE IW930 COSYCOT INFANT WARMER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. THEREFORE, OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, PREVIOUS SIMILAR INVESTIGATIONS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: INSPECTION OF THE PHOTOGRAPH PROVIDED BY THE CUSTOMER REVEALED A CRACK ON THE BASE NEAR THE CENTRE COLUMN. TWO GAS CYLINDERS WERE ALSO FITTED TO THE UNIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 060502. CONCLUSION: CRACKS TO THE PLASTIC LEG BASE REGION OF THE COSYCOT INFANT WARMER ARE KNOWN TO OCCUR WHEN IT HAS BEEN OVERLOADED. THE MAXIMUM WEIGHT LIMIT FOR THE INFANT WARMERS IS SPECIFIED IN THE INFANT WARMER PRODUCT TECHNICAL MANUAL. THE COMPLAINT DEVICE IS OVER NINE YEARS OLD, IT IS REASONABLE TO EXPECT WEAR AND TEAR. THE CUSTOMER WAS PROVIDED A REPLACEMENT METAL BASE THAT HAS A HIGHER MAXIMUM WEIGHT LIMIT.

    Description of Event or Problem · 1

    THE BIOMED FROM A HOSPITAL IN (B)(6), REPORTED THAT THE BASE OF A IW930 COSYCOT INFANT WARMER WAS CRACKED. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41907 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW930 060502

    Patients

    Seq Age Sex Outcome Treatment
    1