BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR

    MDR report key: 11804047 · Received May 11, 2021

    Report

    Report Number
    2936999-2021-00429
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 19, 2021
    Report Date
    May 11, 2021
    Manufacturer
    MEDIANA CO. LTD.
    Product Code
    OCH
    PMA / PMN Number
    K952222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD A MISSING LCD SEGMENT ON THE SCREEN, IT WAS NOT BEEN DROP AND NO VISIBLE PHYSICAL DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706742 NELLCOR OXIMETER, INFRARED, SPORTING, AVIATION OCH MEDIANA CO. LTD. N20E G01834658

    Patients

    Seq Age Sex Outcome Treatment
    1