BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 1702235 · Received May 14, 2010

    Report

    Report Number
    9611451-2010-00277
    Event Type
    Malfunction
    Date Received
    May 14, 2010
    Report Date
    April 21, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE INFORMATION. UNIT: SERIAL NUMBER: (B)(4), LOT NUMBER: 071113, DATE OF MANUFACTURE; 11/13/2007, SERIAL NUMBER: (B)(4), LOT NUMBER: 080116, DATE OF MANUFACTURE: 01/16/2008. METHOD: THE COMPLAINT DEVICES WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE. AN INVESTIGATION WAS CARRIED OUT BASED ON INFORMATION AND PHOTOGRAPHS PROVIDED BY THE HOSPITAL. RESULTS: INSPECTION OF THE PHOTOGRAPHS OF THE COMPLAINT UNITS SUPPLIED BY THE HOSPITAL SHOW THAT ONE OF THE INFANT WARMER HAS A CRACK IN THE REAR LEFT LEG AND THE OTHER INFANT WARMER HAS CRACKS IN BOTH THE REAR LEFT AND REAR RIGHT LEGS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 071113 OR 080116. CONCLUSION: THE IW932 IS A MOBILE WARMER AND MAY BE SUSCEPTIBLE TO IMPACT DAMAGE DURING TRANSPORT. CRACKING OF THE INFANT WARMER BASES CAN OCCUR FROM A COMBINATION OF OVERLOADING AND DYNAMIC FORCED PLACE ON THE UNIT DURING MOVEMENT IN TRANSIT. THE HOSPITAL REPORTED THAT THE TWO BASES WERE DAMAGED WHILE THE WARMERS WERE BEING TRANSPORTED AROUND THE EDUCATION CENTER. IT IS LIKELY THAT THE DAMAGE WAS CAUSED BY A COMBINATION OF OVERLOADING, TRANSPORT DAMAGE AND OTHER FORCES SUCH AS STAFF LEANING ON THE INFANT WARMER. THE IW900 SERIES INFANT WARMER AND ACCESSORIES SERVICE MANUAL INSTRUCTS THAT THE BASE BE CHECKED ANNUALLY.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO (2) IW932AEK COSYCOT INFANT WARMER BASES HAD BROKEN. THE HOSPITAL REPORTED THAT THESE INFANT WARMERS HAD BEEN USED FOR EDUCATIONAL PURPOSES AND HAD NEVER BEEN USED IN A CLINICAL SETTING. THE HOSPITAL REPORTED THAT THE BASES CRACKED AS THEY WERE BEING MOVED AROUND THEIR EDUCATION CENTER. ACCORDINGLY, THERE WERE NO PATIENT CONSEQUENCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 AND AIR CYLINDER| NEWBORN RESUSICTATION EQUIPMENT| (TWO LARYGOSCOPES, SOME OROPHARYNGEAL AIRWAYS,| ACCESSORIES: OXYGEN| A BAG VALVE MASK AND TWO TOWELS)