BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELCH ALLYN

    MDR report key: 12561243 · Received October 1, 2021

    Report

    Report Number
    12561243
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    October 18, 2020
    Report Date
    September 21, 2021
    Manufacturer
    HYGIA HEALTH SERVICES, INC.
    Product Code
    NPP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRIED TO OBTAIN BLOOD PRESSURE (BP) ON PATIENT AND WELCH ALLYN SOFT BLOOD PRESSURE CUFF KEPT CYCLING. RECOGNIZED THAT THE FLEXIPORT AREA WAS PULLED AWAY FROM CUFF, RENDERING THE BP CUFF INEFFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457912 WELCH ALLYN REPROCESSED BLOOD PRESSURE CUFF NPP HYGIA HEALTH SERVICES, INC. SOFT-11 (10)16-049

    Patients

    Seq Age Sex Outcome Treatment
    1 8030 DA