BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEDS BY GEORGE

    MDR report key: 10577375 · Received September 23, 2020

    Report

    Report Number
    3008830652-2020-00002
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    September 17, 2020
    Report Date
    September 23, 2020
    Manufacturer
    BEDS BY GEORGE, INC.
    Product Code
    OYS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PROBLEM TYPICALLY SEEN WHEN PATIENT OVERLOADS THE SEEM AND EXHIBITS AGGRESSIVE BEHAVIORS (E.G., KICKING) NOT INTENDED BY THE DESIGN PARAMETERS OF THE STANDARD MESH CANOPY (HEAVY DUTY MESH IS RECOMMENDED). HOWEVER, DEALER INSISTS THIS PATIENT DOES NOT EXHIBIT THESE BEHAVIORS AND IS NOT AGGRESSIVE.

    Description of Event or Problem · 1

    (B)(6) WAS CONTACTED BY DEALER ABOUT A TEAR IN THE FABRIC OF A CANOPY ON A HAVEN BED. IN SPECIFIC, THE MESH (STANDARD STRENGTH) PULLED AWAY FROM THE FABRIC IN THE DOOR PANEL. THROUGH AN INVESTIGATION BETWEEN THE DEALER AND THE FAMILY, IT WAS DETERMINED THAT THE PATIENT USING THE BED DID NOT EXHIBIT ANY AGGRESSIVE BEHAVIORS AND WAS USING THE BED WITHIN THE ACCEPTABLE USE AND DESIGN PARAMETERS OF THE STANDARD MESH CANOPY. AT THE CONCLUSION OF THE INVESTIGATION, THERE WAS NO DEFINITIVE REASON FOUND AS TO THE TEAR IN THE MESH AND IT WAS DETERMINED TO BE A MANUFACTURING ANOMALY AND A NEW CANOPY WAS PROVIDED UNDER WARRANTY PROVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042528 BEDS BY GEORGE HAVEN 3000 OYS BEDS BY GEORGE, INC. 3000 BRIDENBACKER 070219

    Patients

    Seq Age Sex Outcome Treatment
    1