BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARD

    MDR report key: 18208867 · Received November 27, 2023

    Report

    Report Number
    18208867
    Event Type
    Malfunction
    Date Received
    November 27, 2023
    Date of Event
    September 3, 2023
    Report Date
    September 28, 2023
    Manufacturer
    HARD MFG. CO., INC.
    Product Code
    FMS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A HARD MFG. CO. PEDIATRIC CRIB WITH CRIB TOPPER WAS UTILIZED IN THE CARDIOVASCULAR INTENSIVE CARE UNIT (CICU) AND DURING THE USE OF THE DEVICE CARDIOPULMONARY RESUSCITATION, CPR+ MODE WAS ENGAGED. THE SYSTEM CORRECTLY ACTIVATED CPR MODE, HOWEVER THE DEVICE WAS DIFFICULT TO ADMINISTER CPR DUE TO THE TOPPER BLOCKING THE DOCTOR'S ACCESS. A REQUEST WAS MADE TO REMOVE TOPPERS FOR THE DEVICE DUE TO THIS DESIGN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193698 HARD BED, PEDIATRIC OPEN HOSPITAL FMS HARD MFG. CO., INC. PC1843-CGP

    Patients

    Seq Age Sex Outcome Treatment
    1 90 DA Unknown