BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCUBATOR 8000 IC

    MDR report key: 11881 · Received March 4, 1994

    Report

    Report Number
    49340-1994-00002
    Event Type
    Malfunction
    Date Received
    March 4, 1994
    Date of Event
    February 3, 1994
    Report Date
    February 8, 1994
    Manufacturer
    DRAGERWERK AG
    Product Code
    JTQ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE HEATER OF THE INCUBATOR HAD STOPPED DURING OPERATION WITH A PATIENT. THE DISPLAY FOR THE TEMPERATURE SHOWED DASHES W/O ACOUSTICAL ALARM. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCUBATOR 8000 IC INCUBATOR JTQ DRAGERWERK AG 8000 IC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other