BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIR SHIELDS ISOLETTE INFANT INCUBATOR

    MDR report key: 938044 · Received November 2, 2007

    Report

    Report Number
    2510954-2007-00005
    Event Type
    Other
    Date Received
    November 2, 2007
    Date of Event
    August 19, 2007
    Report Date
    November 2, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED THIS REPORT FORM VIA OUR SUBSIDIARY IN ANOTHER COUNTRY. THE REPORT INDICATED THAT THE LATCH TO SECURE THE ACCESS DOOR WAS DIFFICULT TO OPERATE, AND THE ACCESS DOOR GASKETS WERE INCORRECTLY INSTALLED. IN ADDITION, THERE WERE PHOTOGRAPHS OF THE GASKET IN QUESTION WHICH IS DIFFERENT FROM THE GASKETS SUPPLIED WITH THE DEVICE. THE USER FACILITY HAS ALREADY REPLACED THE ACCESS DOOR, ACCESS DOOR GASKETS, AND THE LATCHES. WE HAVE NOT RECEIVED CONFIRMATION THAT THE SUBJECT PARTS ARE AVAILABLE FOR EVALUATION. THE OPERATORS MANUAL FOR THE C2000 PROVIDES THE USER WITH REASSEMBLY INSTRUCTIONS OF THE ACCESS DOOR GASKETS, AND ALSO PRESCRIBES OPERATIONAL CHECKOUT PROCEDURES TO ASSURE PROPER OPERATION OF THE ACCESS DOOR AND LATCHES BETWEEN EACH USE. BASED ON THE ABOVE INFORMATION, NO CONCLUSION CAN BE DRAWN IN DETERMINING THE CAUSE OF THE EVENT. IF WE RECEIVE ANY ADD'L PERTINENT INFORMATION RELATING TO THIS EVENT, WE WILL ISSUE A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    DURING USE ON PT, IT IS ALLEGED THAT THE FRONT LEFT ACCESS DOOR OF THE INCUBATOR WAS PUSHED OPENED BY THE BABY, AND THE PT FELL FROM THE INCUBATOR TO THE FLOOR THROUGH THE ACCESS DOOR. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR SHIELDS ISOLETTE INFANT INCUBATOR INFANT INCUBATOR FMZ DRAEGER MEDICAL SYSTEMS, INC. C2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR