BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCO-5M

    MDR report key: 5466414 · Received February 24, 2016

    Report

    Report Number
    MW5060561
    Event Type
    Injury
    Date Received
    February 24, 2016
    Date of Event
    January 24, 2016
    Report Date
    February 24, 2016
    Manufacturer
    SANYO/PANASONIC
    Product Code
    MQG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    IN-VITRO FERTILIZATION CLINIC THIRTEEN EMBRYOS BELONGING TO ONE PATIENT EXPERIENCED SIGNIFICANT DEVELOPMENTAL DELAY AND POSSIBLE CELLULAR ARREST DUE TO AN INCUBATOR MALFUNCTION. THERE WAS NO PHYSICAL HARM TO THE PATIENT INVOLVED. THIS IS NOT A DEVICE OR PRODUCT, IT'S A PIECE OF EQUIPMENT. THIS EVENT INVOLVES AN INCUBATOR. A FAILURE OF THE LED RH PAN LIGHT ON DISPLAY SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113039 MCO-5M MCO-5M MQG SANYO/PANASONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Disability