BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY

    MDR report key: 11919731 · Received June 2, 2021

    Report

    Report Number
    11919731
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    May 11, 2021
    Report Date
    May 11, 2021
    Manufacturer
    HILL-ROM, INC.
    Product Code
    KNC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MD HAD DIFFICULTY PERFORMING SUPRAPUBIC PRESSURE ON A LABORING MOTHER AS THE BED KEPT ROLLING. IT WOULD NOT LOCK- BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816414 AFFINITY TABLE, OBSTETRIC (AND ACCESSORIES) KNC HILL-ROM, INC. P3700

    Patients

    Seq Age Sex Outcome Treatment
    1 9490 DA