BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLETTE INFANT INCUBATOR

    MDR report key: 99084 · Received June 12, 1997

    Report

    Report Number
    2510954-1997-00003
    Event Type
    Malfunction
    Date Received
    June 12, 1997
    Report Date
    June 11, 1997
    Manufacturer
    AIR SHIELDS, INC.
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OPTIONAL MONITOR SHELVES HAD BECOME DETACHED FROM THEIR MOUNTING POLES. FAILURES WERE REPORTED TO HAVE OCCURRED DURING INSTALLATION AND DURING USE WHEN NURSES ATTEMPTED TO SWIVEL THE SHELF TO CHANGE ITS POSITION. NO INJURIES OR DAMAGE TO OTHER EQUIPMENT HAS BEEN REPORTED TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLETTE INFANT INCUBATOR NEONATAL INCUBATOR FMZ AIR SHIELDS, INC. C2HS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA