BEUDAMED
    FDA Adverse Event Death Summary report: N

    OOK SNOW

    MDR report key: 16380158 · Received February 15, 2023

    Report

    Report Number
    3009591865-2023-00002
    Event Type
    Death
    Date Received
    February 15, 2023
    Date of Event
    December 31, 2022
    Report Date
    March 14, 2023
    Manufacturer
    UMANO MEDICAL INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON JANUARY 18, 2023, A MEMBER OF MANUFACTURER'S TECHNICAL SERVICE TEAM WAS DISPATCHED TO THE FACILITY TO INSPECT THE BED AND GATHER INFORMATION REGARDING THE ACCIDENT. HE INSPECTED ALL THE FEATURES OF THE BED (I.E., NURSE CALL SYSTEM, BED EXIT ALARM, DETECTION EVENT LOG, MATTRESS THICKNESS ETC.). HE ALSO TESTED THE GAPS BETWEEN THE SIDERAILS, USING THE SAME BED CONFIGURATION AS THAT WHICH EXISTED AT THE TIME OF THE ACCIDENT. THE GAPS WERE CONSISTENT AND COMPLIANT WITH THE DIMENSIONS MENTIONED IN THE STANDARD IEC 60601-2-52. NO FAILURE OR DYSFUNCTION OF THE BED WAS FOUND. AT THIS STAGE, BASED ON THE INVESTIGATION AND ANALYSIS OF AVAILABLE INFORMATION, MANUFACTURER BELIEVES (A) THAT THE BED WAS FULLY FUNCTIONAL, AND COMPLIANT WITH APPLICABLE SPECIFICATIONS AND STANDARDS, AT THE TIME OF THE ACCIDENT; (B) THAT THE SIDERAILS OF THE BED WERE CORRECTLY INSTALLED AND IN PROPER WORKING ORDER; AND (C) THAT NO MALFUNCTION OF THE BED CAUSED OR CONTRIBUTED TO THE ACCIDENT. MANUFACTURER HAS TAKEN STEPS TO OBTAIN A COPY OF THE CORONER'S REPORT, TO BE ABLE TO BE ABLE TO COMPLETE ITS INVESTIGATION AND CONFIRM THE CAUSES AND CIRCUMSTANCES THAT LED TO THE DEATH OF THE PATIENT.

    Additional Manufacturer Narrative · 0

    FURTHER TO OUR INITIAL REPORT, WE FOLLOWED UP WITH THE FACILITY, AND THERE WAS APPARENTLY A MISCOMMUNICATION ON THEIR PART, SINCE WE WERE ADVISED RECENTLY OF THE FOLLOWING: A DOCTOR AT THE FACILITY MADE A REQUEST FOR A CORONER'S INQUEST WITH THE BUREAU DU CORONER OF (B)(6) WHILE PROVIDING THE PERTINENT INFORMATION REGARDING THE ACCIDENT. AFTER REVIEWING THE REQUEST AND THE INFORMATION PROVIDED, THE BCQ DECLINED TO INITIATE AN INQUEST, BASED UPON ITS CONCLUSION THAT THERE WAS NO NEGLIGENCE OR WANT OF CARE OR SUPERVISION BY PERSONNEL AT THE FACILITY THAT PLAYED A ROLE IN THE ACCIDENT, WHICH INCLUDES OUR PRODUCT. AS A RESULT, WE HEREBY CONFIRM, AS OUR FINAL REPORT, THAT NOTHING ESTABLISHES, OR LEADS US TO BELIEVE, IN ANY WAY, THAT OUR PRODUCT WAS DEFECTIVE OR WAS DIRECTLY OR INDIRECTLY THE CAUSE OF THE ACCIDENT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED AN EMAIL FROM THE INITIAL REPORTER (AN ERGO-THERAPIST) EMPLOYED BY THE FACILITY DISCLOSING THAT AN ACCIDENT HAD OCCURRED, INVOLVING ONE OF MANUFACTURER'S MEDICAL PRODUCTS (THE "BED") THAT RESULTED IN THE DEATH OF A PERSON UNDER THE FACILITIES CARE (THE "PATIENT"). THE PATIENT WAS DISCOVERED BY PERSONNEL OF THE FACILITY IN A SEMI-PRONE POSITION WITH HER ARM HANGING OUTSIDE OF THE BED AND HER NECK RESTING ON THE TOP OF THE LEFT HEAD SIDERAIL OF THE BED. THE INITIAL REPORTER MENTIONED THAT THE PATIENT HAD A MAJOR NEUROCOGNITIVE DISORDER, WAS PRONE TO SPASMS, AND WAS AGITATED PRIOR TO THE ACCIDENT. INITIAL REPORTER ALSO INDICATED THAT, AT THE TIME OF THE ACCIDENT, THE LEFT SIDERAILS OF THE BED WERE FULLY RAISED AND ALL ACTIONS TO REDUCE ENTRAPMENT RISKS HAD BEEN PUT IN PLACE BY THE FACILITY, INCLUDING THE INSTALLATION OF THE SIDERAIL PADS.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED AN EMAIL FROM THE INITIAL REPORTER (AN ERGO-THERAPIST) EMPLOYED BY THE FACILITY DISCLOSING THAT AN ACCIDENT HAD OCCURRED, INVOLVING ONE OF MANUFACTURER'S MEDICAL PRODUCTS (THE "BED") THAT RESULTED IN THE DEATH OF A PERSON UNDER THE FACILITIES CARE (THE "PATIENT"). THE PATIENT WAS DISCOVERED BY PERSONNEL OF THE FACILITY IN A SEMI-PRONE POSITION WITH HER ARM HANGING OUTSIDE OF THE BED AND HER NECK RESTING ON THE TOP OF THE LEFT HEAD SIDERAIL OF THE BED. THE INITIAL REPORTER MENTIONED THAT THE PATIENT HAD A MAJOR NEUROCOGNITIVE DISORDER, WAS PRONE TO SPASMS, AND WAS AGITATED PRIOR TO THE ACCIDENT. INITIAL REPORTER ALSO INDICATED THAT, AT THE TIME OF THE ACCIDENT, THE LEFT SIDERAILS OF THE BED WERE FULLY RAISED AND ALL ACTIONS TO REDUCE ENTRAPMENT RISKS HAD BEEN PUT IN PLACE BY THE FACILITY, INCLUDING THE INSTALLATION OF THE SIDERAIL PADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927133 OOK SNOW HOSPITAL BED FNL UMANO MEDICAL INC. FL36

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death