BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLETTE 8000

    MDR report key: 12566000 · Received October 1, 2021

    Report

    Report Number
    2510954-2021-00005
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    July 19, 2021
    Report Date
    May 31, 2022
    Manufacturer
    DRAEGER MEDICAL INFANT CARE, INC.
    Product Code
    FMZ
    PMA / PMN Number
    K001242
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE CUSTOMER CALLED DRAEGER SERVICE FOR A FIELD CHECK. HOWEVER IT WAS CLARIFIED THAT THE DEVICE WAS EVALUATED BY THE BIOMEDICAL TECHNICIAN WITH NO PROBLEM FOUND. THE DEVICE WAS POWER OFF FOR A PERIOD OF TIME, THEN POWERED UP AGAIN. ADDITIONAL INFORMATION PROVIDED NOTING THAT THE DEVICE DID NOT PROVIDE ANY ALARM PRIOR TO SHUTTING DOWN. AS THE REPORTED ISSUE COULD NOT BE RECREATED, ROOT CAUSE CANNOT BE ESTABLISHED. NOTE THAT THIS CASE WAS INITIALLY REPORTED UNDER MDR# 1220063-2021-00023 IN ERROR, THE CORRECT MDR# IS 2510954-2021-00005.: THE DEVICE WAS EVALUATED BY THE BIOMEDICAL TECHNICIAN WITH NO PROBLEM FOUND.

    Additional Manufacturer Narrative · 0

    DUE TO A TECHNICAL ISSUE WITH OUR INTERNAL EMDR SYSTEM WE SUBMITTED FOR THE FORM FDA 3500A AN INCORRECT VALUE FOR THE FIELD H3. - NOT RETURNED TO MANUFACTURER H3 OTHER TEXT : THE DEVICE WAS EVALUATED BY THE BIOMEDICAL TECHNICIAN WITH NO PROBLEM FOUND.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED WHERE IS WAS REPORTED THAT THE STAFF FOUND THAT THE ISOLETTE 8000 INCUBATOR WAS SUDDENLY POWERED OFF DURING USE. AFTER DISCOVERING THE PROBLEM, IMMEDIATELY USE THE SPARE INSTRUMENT TO CONTINUE THE TREATMENT. THOUGH NO ADVERSE PATIENT IMPACT WAS REPORTED, AN UNEXPECTED SHUTDOWN OF THE INCUBATOR RESULTING IN THE BABY BEING TRANSFERRED TO A NEW DEVICE INDICATES A POSSIBLE INTERRUPTION/DELAY OF THERAPY. ADDITIONALLY IT WAS STATED THAT THE DEVICE WAS POWERED OFF AND AFTER A PERIOD OF TIME, POWERED ON AGAIN WITH NO ISSUES.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED WHERE IS WAS REPORTED THAT THE STAFF FOUND THAT THE ISOLETTE 8000 INCUBATOR WAS SUDDENLY POWERED OFF DURING USE. AFTER DISCOVERING THE PROBLEM, IMMEDIATELY USE THE SPARE INSTRUMENT TO CONTINUE THE TREATMENT. THOUGH NO ADVERSE PATIENT IMPACT WAS REPORTED, AN UNEXPECTED SHUTDOWN OF THE INCUBATOR RESULTING IN THE BABY BEING TRANSFERRED TO A NEW DEVICE INDICATES A POSSIBLE INTERRUPTION/DELAY OF THERAPY. ADDITIONALLY IT WAS STATED THAT THE DEVICE WAS POWERED OFF AND AFTER A PERIOD OF TIME, POWERED ON AGAIN WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463581 ISOLETTE 8000 INFANT INCUBATOR WITH OXYGEN, SCALE AND HUMIDITY FMZ DRAEGER MEDICAL INFANT CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention