BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSABLE

    MDR report key: 3865899 · Received April 28, 2014

    Report

    Report Number
    3865899
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 19, 2014
    Report Date
    April 28, 2014
    Manufacturer
    VITAL SIGNS
    Product Code
    KZD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    ARTERIAL LINE PRESSURE BAG RIPPED AT THE SEAM WHILE INFLATING THE BAG FOR SET-UP. THE NURSING STAFF REPORTS THAT THIS IS HAPPENING NOT INFREQUENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253594 INFUSABLE PRESSURE INFUSOR KZD VITAL SIGNS IN-900012 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *