BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELCH ALLYN

    MDR report key: 10934284 · Received December 2, 2020

    Report

    Report Number
    10934284
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 8, 2020
    Report Date
    November 10, 2020
    Manufacturer
    HYGIA HEALTH SERVICES, INC.
    Product Code
    NPP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE ON A PEDIATRIC CALL WITH LIFEPACT TEAM, SIZE 10 SMALL ADULT CUFF HAD BROKEN. THE PLASTIC PIECE WHERE THE MONITOR CLIPS HAD COME OFF COMPLETELY MAKING THE CUFF UNABLE TO USE. HAD TO USE SMALLER SIZE CUFF FOR THE PATIENT ON THE CALL. WHEN BACK IN STORAGE, FOUND THAT 5 OTHER SIZE 10 CUFFS HAD BROKEN CLIPS THAT WERE UNABLE TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1396907 WELCH ALLYN REPROCESSED BLOOD PRESSURE CUFF NPP HYGIA HEALTH SERVICES, INC. SOFT-10 30046581A

    Patients

    Seq Age Sex Outcome Treatment
    1 4380 DA