BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARD

    MDR report key: 16408295 · Received February 21, 2023

    Report

    Report Number
    16408295
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    March 1, 2022
    Report Date
    February 6, 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

    NUMEROUS HARD CRIBS HAVE FAILED; THE ZIP-TIES, PROVIDED BY THE COMPANY, TO HOLD THE PLASTIC TOPPER OF THE CRIB ARE BREAKING. DURING THE INITIAL INSTALLATION OF THE CRIB, THE ZIP-TIES BROKE MAKING THE PLASTIC SCREEN OF THE CRIB USELESS. THE COMPANY PROVIDED THE HOSPITAL WITH STRONGER ZIP-TIES. HOWEVER, THE HAVE BEEN MULTIPLE ISSUES WITH THE STRONGER ZIP-TIES BREAKING TOO. THE HARD CRIBS ARE UNDER EXPECTED PATIENT USE, AND THERE IS NOTHING HEAVY BEING HELD IN THE PLASTIC TOPPER POCKETS. THERE IS A POSSIBILITY OF PATIENT HARM WHEN THE ZIP-TIES BREAK, AND THE PLASTIC TOPPER CAN NO LONGER PREVENT A CHILD FROM CLIMBING OVER THE CRIB. THE COMPANY HAS BEEN CONTACTED, AND THEY ARE AGAIN SENDING EXTRA TENSILE ZIP-TIES FOR THIS ISSUE. MANUFACTURER RESPONSE FOR CRIB, HARD (PER SITE REPORTER). MANUFACTURER HAS RESPONDED BY SENDING MORE ZIP-TIES. HARD REPORTED THAT THEY DID NOT HAVE REPORTS OF THIS ISSUE FROM OTHER SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967249 HARD BED, PEDIATRIC OPEN HOSPITAL FMS HARD MFG. CO., INC. 12568

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown