BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 7301948 · Received February 27, 2018

    Report

    Report Number
    9611451-2018-00158
    Event Type
    Malfunction
    Date Received
    February 27, 2018
    Date of Event
    January 26, 2018
    Report Date
    January 29, 2018
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) METHOD: THE COMPLAINT INFANT WARMER HEAD WAS NOT RETURNED TO FISHER AND PAYKEL HEALTHCARE FOR EVALUATION. OUR INVESTIGATION IS BASED ON PHOTOGRAPHS OF THE DAMAGED WARMER HEAD AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE PHOTOGRAPHS PROVIDED SHOWED THAT THE COMPLAINT WARMER HEAD DOES NOT HAVE ANY HEAD CLIPS ON IT. THE WARMER HEAD OF OTHER UNITS MANUFACTURED IN 2002 HAD HEAD CLIPS ON IT. THE HEAD CLIPS WERE INTRODUCED IN APRIL 2002 AS AN ADDITIONAL LAYER OF SAFETY TO PREVENT THE SCREW BOSS BREAKING AND THE GRILLE DETACHING FROM THE HEAD. THE PHOTOGRAPHS ALSO REVEALED THAT THE COMPLAINT WARMER HEAD HAD A REV A LABEL, WHEREAS ALL UNITS MANUFACTURED POST 20 AUGUST 1997 SHOULD HAVE A REV B LABEL. AS THE WARMER HEADS ARE DETACHABLE, IT IS LIKELY THAT THE COMPLAINT HEAD BELONGS TO A MUCH OLDER UNIT AND WAS ATTACHED TO THE NEW UNIT DURING SERVICING. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 020718. CONCLUSION: THE IW900 SERIES INFANT WARMER HEAD WAS MODIFIED IN AUGUST 2002 EMPLOYING A SECOND SCREW AND A REAR METAL BRACKET TO FASTEN THE UPPER AND LOWER CASES TOGETHER. A REPLACEMENT HEATER HEAD HAS BEEN SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT A IW960AGU WALL MOUNT COSYCOT INFANT WARMER'S LIGHTING FIXTURE SUDDENLY DISINTEGRATED AND FELL INTO THE BASSINET WHEN THE SCREW BOSS DETACHED FROM THE GRILLE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145130 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW960 020718

    Patients

    Seq Age Sex Outcome Treatment
    1