BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELCH ALLYN

    MDR report key: 8615483 · Received May 16, 2019

    Report

    Report Number
    8615483
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    April 29, 2019
    Report Date
    May 2, 2019
    Manufacturer
    HYGIA HEALTH SERVICES, INC.
    Product Code
    NPP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BLOOD PRESSURE CUFF EXPLODED WHILE INFLATING ON PATIENTS ARM. TOTAL OF 3 OCCURRENCES ON THIS DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411666 WELCH ALLYN REPROCESSED BLOOD PRESSURE CUFF NPP HYGIA HEALTH SERVICES, INC. SOFT-11

    Patients

    Seq Age Sex Outcome Treatment
    1