BEUDAMED
    FDA Adverse Event Death Summary report: N

    OOK SNOW

    MDR report key: 18839736 · Received March 5, 2024

    Report

    Report Number
    3009591865-2023-00020
    Event Type
    Death
    Date Received
    March 5, 2024
    Date of Event
    November 14, 2023
    Report Date
    December 13, 2023
    Manufacturer
    UMANO MEDICAL INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON DECEMBER 1ST 2023, UMANO REPRESENTATIVE WAS CONTACTED REGARDING THE INCIDENT AT CLIENT'S SITE. THROUGH THE INITIAL COMMUNICATION FROM THE CUSTOMER, THEY MENTIONED THAT THEY BELIEVE THE INCIDENT MAY BE CAUSED BY AN ERROR USE (FOOTBOARD REMOVED OR BED SOMETIME UNPLUGED BY RESIDENT). UMANO REPRESENTATIVE WENT ON SITE ON DECEMBER 8, 2023 AND ON DECEMBER 11, 2023 TO PERFORM INVESTIGATION. DURING THE INVESTIGATION, THE BED WAS TESTED AND IT WAS CONCLUDED THAT THE BED EXIT MONITORING SYSTEM DETECTION WAS FULLY FUNCTIONAL. FURTHER VERIFICATIONS WERE MADE BY THE SERVICE TECHNICIAN AND HE NOTICE THAT THE BED HISTORY LOG SHOWED THAT THE CUSTOMER PERFORM THE ZEROING PROCEDURE ON THE BED FOR THE FIRST TIME ON (B)(6) 2023, TWO DAYS AFTER THE INCIDENT. THE USER MANUAL STATES THE ZEROING PROCEDURE MUST BE PERFORMED PRIOR TO INSTALLING A NEW PATIENT OR ACCESSORY ON THE BED. THE BED IS FULLY FUNCTIONAL AT CUSTOMER SITE, NO ACTION REQUIRED. THE MOST PROBABLE CAUSE IS AN ERROR USE NOTE: 2024-03-05: RESUBMITTING REPORT IN PRODUCTION ENVIRONMENT. KINDLY SEE ATTACHMENT.

    Description of Event or Problem · 0

    UMANO MEDICAL REPRESENTATIVE WAS CONTACTED BY CUSTOMER ON (B)(6) 2023 REGARDING AN INCIDENT THAT HAPPENED ON (B)(6) 2023 ALLEDGING THAT THE BED EXIT MONITORING SYSTEM MAY HAVE NOT BEEN WORKING OR USED PROPERLY. CUSTOMER ADDED THAT THE PATIENT FELL FROM THE BED, WHICH CAUSE A FRACTURE OF HER ELBOW AND HIP AND DECEASED 10 DAYS LATER. ALTHOUGH NOT CONFIRMED, THE CUSTOMER MENTIONED THAT THE FRACTURE MAY HAVE CONTRIBUTED TO THE DEATH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583489 OOK SNOW HOSPITAL BED FNL UMANO MEDICAL INC. FL36

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death