BEUDAMED
    FDA Adverse Event Summary report: N

    INCUBATOR 8000

    MDR report key: 2171433 · Received February 28, 2007

    Report

    Report Number
    9611500-2007-00007
    Date Received
    February 28, 2007
    Report Date
    February 26, 2007
    Manufacturer
    DRAGER MEDICAL AG & CO. KG
    Product Code
    FMZ
    PMA / PMN Number
    K913394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DRAGER TRIED TO GET ACCESS TO THE DEVICE AND INFO. HOSP DID NOT RELEASE ANY INFO OR THE CORRESPONDING DEVICE FOR INVESTIGATION UNTIL NOW. FURTHER INFO WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    AT 22:00 HRS THE INCUBATOR HUMIDITY WENT OFF FOR AN HOUR, TURNED ON AGAIN AT 23:00. AT 05:00 THE BABY'S ((B)(4)) TEMP DROPPED TO 36.2 DEGREES CENTIGRADE. INCUBATOR HUMIDITY INOPERATIVE. NEONATE TRANSFERRED TO ANOTHER WORKING UNIT. INCUBATOR IS QUARANTINED AT THE HOSPITAL SITE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention