BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM1000

    MDR report key: 13892885 · Received March 24, 2022

    Report

    Report Number
    3009591865-2022-00005
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    February 22, 2022
    Report Date
    April 25, 2022
    Manufacturer
    UMANO MEDICAL INC.
    Product Code
    FNL
    UDI-DI
    00670482000487
    Removal / Correction Number
    RES#90058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A RECALL HAS BEEN INITIATED ON THE 11TH OF APRIL 2022 BY UMANO MEDICAL INC RELATED TO THIS PROBLEM. THE MOTORIZED WHEEL SOFTWARE WILL BE MODIFIED TO ADD MONITORING CONDITIONS TO CONTINUOUSLY MONITOR THE MOTOR STATUS INCLUDING WHEN IT SHOULD NOT BE RUNNING. THIS RECALL NUMBER RES#: 90058 IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    DISTRIBUTER CONTACTED TECHNICAL SERVICE OF THE MANUFACTURER TO REPORT AN ISSUE WITH THE MOTORIZED WHEEL SYSTEM OF A HOSPITAL BED THAT WAS BEING USED BY ONE OF HIS CUSTOMERS DURING A TRIAL SESSION (THE BED WAS NOT IN USE WITH A PATIENT) HE MENTIONED THAT WHEN THEY RELEASED THE TRIGGER TO STOP THE WHEEL MOVEMENT, THE BED CONTINUED TO MOVE FORWARD AND WAS STOPPED AGAINST THE WALL. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703943 FREEDOM1000 HOSPITAL BED FNL UMANO MEDICAL INC. FM1000 00670482000487

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown