BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BED, AC-POWERED ADJUSTABLE HOSPITAL

    MDR report key: 20160448 · Received September 6, 2024

    Report

    Report Number
    3009591865-2024-00007
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 9, 2024
    Report Date
    June 11, 2025
    Manufacturer
    UMANO MEDICAL INC.
    Product Code
    FNL
    UDI-DI
    00670482000487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UMANO MEDICAL INITIALLY RECEIVED A COMPLAINT REGARDING A MALFUNCTION IN THE BED EXIT SYSTEM, SPECIFICALLY THAT THE SIGNAL WAS NOT REACHING THE NURSE CALL STATION. DURING A REMOTE TROUBLESHOOTING SESSION WITH THE CLIENT, THE ISSUE WAS IDENTIFIED AS A FAILURE OF THE ELECTRONIC MAIN BOARD. A REPLACEMENT PART WAS PROMPTLY SHIPPED TO THE CLIENT ON 2024-08-09 TO FACILITATE THE REPAIR. A PRELIMINARY MEDICAL DEVICE REPORT (MDR) WAS PROACTIVELY INITIATED, ALTHOUGH CONFIRMATION OF THE COMPLETED REPAIR HAD NOT BEEN RECEIVED AT THAT TIME. DESPITE MULTIPLE FOLLOW-UP ATTEMPTS VIA EMAIL AND TELEPHONE, THE CLIENT DID NOT CONFIRM WHETHER THE REPAIR HAD BEEN CARRIED OUT. THE MOST RECENT FOLLOW-UP, CONDUCTED ON 2025-06-06, WAS ALSO UNSUCCESSFUL. HOWEVER, GIVEN THAT 10 MONTHS HAVE PASSED SINCE THE REPLACEMENT PART WAS SHIPPED, AND CONSIDERING THAT THE MANUFACTURER MADE FIVE FOLLOW-UP ATTEMPTS USING VARIOUS COMMUNICATION METHODS, IT IS REASONABLE TO CONCLUDE THAT THE REPAIR WAS COMPLETED AND THAT THE DEVICE IS NOW FUNCTIONING AS INTENDED. BASED ON THE AVAILABLE INFORMATION, UMANO MEDICAL CONFIRMS THAT THE ROOT CAUSE OF THE ISSUE WAS A FAILURE OF THE ELECTRONIC MAIN BOARD COMPONENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO UMANO MEDICAL REPRESENTATIVE THAT THE BED IS NOT SENDING SIGNAL TO THE HOSPITAL'S NURSE CALL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384727 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL UMANO MEDICAL INC. FM1000 00670482000487

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown