BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCUBATOR 8000SC

    MDR report key: 1612558 · Received February 12, 2010

    Report

    Report Number
    9611500-2010-00008
    Event Type
    Injury
    Date Received
    February 12, 2010
    Report Date
    August 12, 2008
    Manufacturer
    DRAGER MEDICAL AG & CO. KG
    Product Code
    FMZ
    PMA / PMN Number
    K913394
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT HAS BEEN FIRST TIME NOTICED/REPORTED ON JANUARY, 14TH 2010 TO THE MANUFACTURER. THE AFFECTED HOSPITAL HAS BEEN REQUESTED FOR FURTHER DETAILS OF THE EVENT; ANSWER IS PENDING. THE INVESTIGATION REVEALED, THAT THE INCUBATOR IN QUESTION WAS PERIODICALLY MAINTAINED ACC. MANUFACTURER'S SERVICE SCOPE AND NO CONSPICUOUSNESS HAS BEEN NOTICED DURING THOSE SERVICE TASKS. ACCORDING TO MANUFACTURER'S STATED INFORMATION, THE DEVICE IS STILL IN USE SINCE THE REPORTED EVENT. IF INFORMATION BECOMES AVAILABLE THAT ALLOWS FURTHER INVESTIGATION, THE RESULTS WILL BE REPORTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE MANUFACTURER HAS BEEN ACTUALLY REQUESTED BY AN EXTERNAL LETTER ON DETAILS OF MAINTENANCE AND ITS RESULTS OF A SPECIFIC INCUBATOR DEVICE. THE ENQUIRY TO THE SENDER OF THE LETTER RESULTED IN THE INFORMATION THAT AN INCIDENT HAPPENED ON (B) (6) 2008, A (B) (6) CHILD WHILE RECEIVING PHOTOTHERAPY HAS FALLEN OUT OF THE INCUBATOR. IT WAS FURTHER REPORTED BY THE SENDER THAT THE PATIENT HAS FALLEN THROUGH ONE OF THE HANDPORTS OF THE DEVICE. THIS INCIDENT HAS BEEN FIRST TIME NOTICED/REPORTED ON JANUARY 14TH, 2010 TO THE MANUFACTURER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening