BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL COSYCOT INFANT WARMER

    MDR report key: 5209742 · Received November 8, 2015

    Report

    Report Number
    9611451-2015-00465
    Event Type
    Malfunction
    Date Received
    November 8, 2015
    Date of Event
    October 17, 2015
    Report Date
    October 20, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT IW934JEU BABY CONTROL COSYCOT INFANT WARMER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. OUR ANALYSIS IS ACCORDINGLY BASED ON THE PHOTOGRAPH PROVIDED BY THE HEALTHCARE FACILITY AND RESULTS OF OUR PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS. RESULTS: THE PHOTOGRAPH SHOWED THAT THERE WAS A NOTICEABLE BIG CRACK AT THE CENTRE OF THE PLASTIC BASE COLUMN. IT ALSO SHOWED THAT THE SUBJECT INFANT WARMER WAS LOADED WITH TWO LARGE GAS BOTTLES AND A UPS MACHINE. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 070205. CONCLUSION: CRACKING OF THE COSYCOT INFANT WARMER PLASTIC BASE CAN OCCUR FROM OVERLOADING. IN THIS INSTANCE, THE APPROXIMATE COMBINED WEIGHT OF THE INFANT WARMER UNIT AND ITS ACCESSORIES POSSIBLY EXCEEDED THE RECOMMENDED MAXIMUM LOAD. THE MAXIMUM WEIGHT LIMIT IS SPECIFIED IN THE OPERATING MANUAL AND IN THE PRODUCT TECHNICAL MANUAL OF THE COSYCOT INFANT WARMER. TO INCREASE AWARENESS AND TO PREVENT AND/OR REDUCE THE INCIDENCE OF CRACKED PLASTIC BASES, FPH STATES THAT THE MAXIMUM WEIGHT ON THE INFANT WARMER INCLUSIVE OF ALL ACCESSORIES AND THE PATIENT SHOULD NOT EXCEED 115KG. THIS WARNING IS PROVIDED IN THE FORM OF LABELS ON THE COLUMN OF THE INFANT WARMER. IN ADDITION, A CHECKLIST OF COMMON FISHER & PAYKEL HEALTHCARE ACCESSORIES AND THEIR RESPECTIVE WEIGHTS IS PROVIDED TO THE USER.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A DISTRIBUTOR THAT THE PLASTIC BASE OF AN IW934JEU BABY CONTROL COSYCOT INFANT WARMER WOULD NOT RISE. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739790 BABY CONTROL COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW934JEU

    Patients

    Seq Age Sex Outcome Treatment
    1