BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALEO

    MDR report key: 1675598 · Received April 28, 2010

    Report

    Report Number
    1675598
    Event Type
    Malfunction
    Date Received
    April 28, 2010
    Date of Event
    April 26, 2010
    Report Date
    April 27, 2010
    Manufacturer
    DRAGER MEDICAL
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US

    Narratives

    Description of Event or Problem · 1

    THE CANOPY IS BECOMING CRACKED, ESPECIALLY AROUND THE HOLE IN THE TOP. THE HOSPITAL BELIEVES THE CRACKS APPEAR TO BE HEAT STRESS FRACTURES. THE HOSPITAL HAS BEEN USING CAVICIDE AS THE CLEANING/DISINFECTANT AGENT FOR THE LAST 3 TO 4 MONTHS INSTEAD OF KLEENASPETIC (MADE BY DRAEGER), WHICH IS RECOMMENDED FOR USE WITH THE CALEO INCUBATOR. DRAEGER HAS DISCONTINUED MAKING KLEENASPETIC AND IT IS NO LONGER AVAILABLE FOR PURCHASE. THE SALES REP BELIEVES WE ARE USING AN "UNAPPROVED" CLEANER. THESE FRACTURES DO NOT APPEAR TO BE THAT TYPE OF FRACTURE AND THE CLEANER BEING USED IS AN INDUSTRY STANDARD CLEANER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALEO INFANT INCUBATOR FMZ DRAGER MEDICAL CALEO *

    Patients

    Seq Age Sex Outcome Treatment
    1 * OTHER