BEUDAMED
    FDA Adverse Event Death Summary report: N

    CALEO

    MDR report key: 1022523 · Received March 31, 2008

    Report

    Report Number
    9611500-2008-00016
    Event Type
    Death
    Date Received
    March 31, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 27, 2008
    Manufacturer
    DRAEGER MEDICAL AG & CO. KG
    Product Code
    FMZ
    PMA / PMN Number
    K003067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    IF THE REPORTED TRANSFER OF THE PT DURING TREATMENT CONTRIBUTED TO THE REPORTED DEATH COULD NOT BE CONCLUDED SO FAR. THE INVESTIGATION OF THE REPORTED EVENT IS ONGOING. ON-SITE INVESTIGATION AND DISCUSSION IS PLANNED FOR CW 14. FURTHER RESULTS WILL BE REPORTED IN A FOLLOW-UP/FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE NIGHT, AND THE NEXT MORNING A SERIOUSLY ILL PATIENT WAS BEING TREATED IN A CALEO INCUBATOR; THE USERS WERE CONTINUALLY OBSERVING AN ERROR CODE 31 BEING POSTED ON THE DEVICE. THE USERS IN RESPONSE TO THIS ERROR CODE MOVED THE PT TO ANOTHER CALEO INCUBATOR, AGAIN THE ERROR CODE 31 WAS DISPLAYED. IT IS UNDERSTOOD THAT THE PT WAS TRANSFERRED WITH THE SAME TEMPERATURE PROBE STILL ATTACHED TO THEM AND THE TEMPERATURE PROBE WAS NOT CHANGED OR REPLACED. THE PT UNFORTUNATELY DIED. IT IS NOT KNOWN IF THE REPORTED ERRORS, AND THE SUBSEQUENT TRANSFER OF THE PT CONTRIBUTED TO THE REPORTED DEATH OF THE PT OR, IF THE CAUSE OF DEATH IS ATTRIBUTED TO THE NATURE OF THE PT'S SERIOUS ILLNESS. THE DEVICES ARE STILL IN USE AT HOSP SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALEO INFANT INCUBATOR FMZ DRAEGER MEDICAL AG & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death