BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISOLETTE

    MDR report key: 18573 · Received December 28, 1994

    Report

    Report Number
    MW1004594
    Event Type
    Other
    Date Received
    December 28, 1994
    Date of Event
    October 26, 1994
    Report Date
    November 22, 1994
    Manufacturer
    AIR-SHIELDS VICKERS
    Product Code
    FMZ
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ISOLETTE ON "SERVO" MODE WITH SKIN PROBE FAILED TO DELIVER HEAT AS SET. INFANT SUFFERED HYPOTHERMIA; PT TEMPERATURE 31.1 DEGREES CENTIGRADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLETTE ISOLETTE FMZ AIR-SHIELDS VICKERS C100

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Other