BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G85 MINI INCUBATOR WITH

    MDR report key: 8436034 · Received March 20, 2019

    Report

    Report Number
    1216677-2019-00133
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Date of Event
    March 12, 2019
    Report Date
    March 20, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    PUB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    OUT OF BOX FAILURE. UNIT OVER HEATING BEYOND SPECS. OUR SERVICE TECH BURNT WHILE TRYING TO SERVICE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228433 G85 MINI INCUBATOR WITH G85 MINI INCUBATOR WITH PUB COOPERSURGICAL, INC. K22074

    Patients

    Seq Age Sex Outcome Treatment
    1 Other