BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRELESS BED/CHAIR MONITOR BC600

    MDR report key: 16033380 · Received December 22, 2022

    Report

    Report Number
    16033380
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    November 4, 2022
    Report Date
    November 30, 2022
    Manufacturer
    CURBELL MEDICAL PRODUCTS, INC.
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UNKNOWN HOW LONG THE CHAIR PAD WAS NOT WORKING PROPERLY. PHYSICAL THERAPY WORKED WITH PATIENT AN PLACE THEM IN THE CHAIR WITH WIRELESS CHAIR DEVICE UNDER THE PATIENT. PATIENT WAS LEFT IN THE CHAIR WITH CALL LIGHT WITH IN REACH. STAFF FOUND PATIENT ON THE FLOOR AS IT APPEARED THEY HAD SLID OUT OF THE CHAIR AND WAS AT THE FOOT OF THE CHAIR UNHARMED. INCIDENT REPORTED AND CHAIR PAD WAS REVIEWED AS NOT APPROPRIATELY FUNCTIONING AND WAS REPLACED WITH A NEW PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880760 WIRELESS BED/CHAIR MONITOR BC600 MONITOR, BED PATIENT KMI CURBELL MEDICAL PRODUCTS, INC. CSM-BC600 2-2022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown