BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCUBATOR 8000

    MDR report key: 514174 · Received March 3, 2004

    Report

    Report Number
    9611500-2004-00004
    Event Type
    Injury
    Date Received
    March 3, 2004
    Date of Event
    January 18, 2004
    Report Date
    March 3, 2004
    Manufacturer
    DRAGER MEDICAL AG & CO. KGAA
    Product Code
    FMZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PREMATURE BABY FELL THROUGH THE INCUBATOR'S HANDPORT AND SUFFERED A CRANIAL FRACTURE AND EFFUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCUBATOR 8000 NEONATAL INCUBATOR FMZ DRAGER MEDICAL AG & CO. KGAA INCUBATOR 8000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN