BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELCH ALLYN

    MDR report key: 19950325 · Received August 9, 2024

    Report

    Report Number
    19950325
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    May 15, 2024
    Report Date
    June 3, 2024
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NPP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THEY HAD A DISPOSABLE BLOOD PRESSURE CUFF THAT WAS HAVING ISSUES WITH LEAKS. IN TURN IT WAS NOT GIVING A CORRECT BLOOD PRESSURE READING. THE OPERATING ROOM WAS SWITCHING OUT THE MACHINES THINKING THE ERROR WAS CAUSED FROM A DEFECTIVE DEVICE. IT WAS IN FACT THE BLOOD PRESSURE CUFF THAT CAUSED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2485279 WELCH ALLYN REPROCESSED BLOOD PRESSURE CUFF NPP STRYKER SUSTAINABILITY SOLUTIONS SOFT-11 24-028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown