BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALL MOUNT INFANT WARMER

    MDR report key: 1061910 · Received June 16, 2008

    Report

    Report Number
    9611451-2008-00367
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Report Date
    May 22, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD.
    Product Code
    FMT
    PMA / PMN Number
    K971461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT NUMBERS: 051012001096, 051012001098, 051012001100, 051012001095, 041201001218, 051017001123, 051012001099. ADDITIONAL MANUFACTURING DATES: 10/12/05, 10/12/05, 10/12/05, 10/12/05. 12/01/04, 10/17/05, 10/12/05. AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND RESULTS OF PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS, AS THE COMPLAINT DEVICES HAVE NOT BEEN RETURNED FOR INVESTIGATIONS. RESULTS: IT WAS REPORTED THAT THE WARMER HEADS OF THE INFANT WARMER BEGAN TO BREAK DOWN DUE TO THE USE OF PRO FIL # 13 ULTRA PLUS. IT IS A CLEANING SOLUTION THAT CONTAINS CHEMICAL INGREDIENT THAT IS NOT RECOMMENDED FOR USE ON THE WARMER HEAD, AS SPECIFIED ON THE OPERATING MANUAL OF THE INFANT WARMER. THE OPERATING MANUAL STATES THAT CLEANING OF ALL PARTS OF THE INFANT WARMER AND ACCESSORIES SHOULD BE DONE AT NORMAL ROOM TEMPERATURE, AROUND 23 DEGREE C, AND TO AVOID CLEANING SOLUTIONS CONTAINING AROMATIC HYDROCARBONS, AMMONIA, AMINES OR AQUEOUS SOLUTIONS AS THESE MAY CAUSE CHEMICAL REACTIONS TO THE POLYCARBONATE PLASTIC MATERIAL. CONCLUSION: REPORTED FAULT WAS CONFIRMED AS USE ERROR. THE DEGRADATION OF THE INFANT WARMER HEAD, DUE TO THE USE OF NON-COMPATIBLE CLEANING MATERIALS, IS A KNOWN PROBLEM. WE HAVE AN OPEN CAPA TO EXAMINE FURTHER COMPATIBLE CLEANING SOLUTIONS.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED THAT EIGHT IW980JEU WALL MOUNT INFANT WARMER HEADS BEGAN TO BREAK DOWN DUE TO THE USE OF DISINFECTANT SOLUTION CONTAINING ACTIVE INGREDIENT THAT IS LISTED IN THE INFANT WARMER OPERATING MANUAL AS NOT RECOMMENDED FOR USE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALL MOUNT INFANT WARMER FMT FISHER & PAYKEL HEALTHCARE LTD. IW980JEU 051012001096

    Patients

    Seq Age Sex Outcome Treatment
    1