BEUDAMED
    FDA Adverse Event Death Summary report: N

    OOK SNOW

    MDR report key: 18839928 · Received March 5, 2024

    Report

    Report Number
    3009591865-2024-00001
    Event Type
    Death
    Date Received
    March 5, 2024
    Date of Event
    December 8, 2023
    Report Date
    January 24, 2024
    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

    2024-01-11: HEALTH CARE FACILITY ("HCF") CONTACTS UMANO MEDICAL ("UM") TO RETROACTIVELY REPORT THE INCIDENT, NAMELY THAT THE PATIENT FELL ON (B)(6) 2023, AND SUBSEQUENTLY DIED ON (B)(6) 2023. 2024-01-15: PURSUANT TO HCF'S REQUEST, REGARDING THE PATIENT FALL, A UM TECHNICIAN CONDUCTS A SITE VISIT AT THE HCF. DURING THE VISIT, THE UM TECHNICIAN CONDUCTS FURTHER TESTS, AND MORE IMPORTANTLY, FULLY REVIEWS THE COMPUTER LOG HISTORY OF THE MEDICAL BED. SUCH REVIEW REVEALS THAT NO ERROR OR MALFUNCTION OF THE MEDICAL BED OCCURED ON (B)(6) 2023. 2024-01-17: TO ENSURE THAT NOTHING IS DISPUTED, ONE OF UM'S TECHNICAL SERVICE LEADERS SEND AN EMAIL TO HCF SUMMARIZING THE ABOVE-MENTIONED FACT AND CONCLUSION. RECEIPT CONFIRMED BY THE HCF. THE BED IS FULLY FUNCTIONAL AT CUSTOMER SITE, NO ACTION REQUIRED. THE MOST PROBABLE CAUSE IS A USER ERROR. NOTE: 2024-03-05: RESUBMITTING REPORT IN PRODUCTION ENVIRONMENT.

    Description of Event or Problem · 0

    BASED ON THE INFORMATION PROVIDED BY THE HEALTH CARE FACILITY ("HCF") ON 2024-01-11 TO UMANO MEDICAL TECHNICAL SERVICE : (B)(6) 2023: THE PATIENT EXITED THE MEDICAL BED , THEREAFTER FELL, WHILE IN ITS DESIGNAGTED ROOM IN THE HCF, NOT CONFIRMED IF THERE WAS ANY INJURY (THE " INCIDENT"). (B)(6) 2023: THE PATIENT DIED FOR A REASON THAT MAY, OR MAY NOT, BE DIRECTLY RELATED TO THE INCIDENT. THE PATIENT WAS ALREADY IN A DETERIORATION PHASE AS INDICATED BY THE HCF REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1882353 OOK SNOW HOSPITAL BED FNL UMANO MEDICAL INC. FL36

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death