BEUDAMED
    FDA Adverse Event Death Summary report: N

    BED, AC-POWERED ADJUSTABLE HOSPITAL

    MDR report key: 19209863 · Received April 29, 2024

    Report

    Report Number
    3009591865-2024-00005
    Event Type
    Death
    Date Received
    April 29, 2024
    Date of Event
    May 12, 2023
    Report Date
    June 11, 2025
    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

    2024-04-02: UM WAS CONTACTED BY A CORONER INQUIRING ABOUT UM'S RECOMMENDATIONS REGARDING THE OPERATION OF THE BED HEIGHT FUNCTION. UM PROVIDED THE INFORMATION REQUESTED BY THE CORONER, INCLUDING, AMONGST OTHER THINGS, THAT, AS SPECIFIED IN THE USER MANUAL, THE HEIGHT OF THE BED MUST BE "ZEROED' BEFORE SETTING FOR PATIENT USE. THE CORONER WAS UNABLE TO PROVIDE THE SERIAL NUMBER OF THE BED INVOLVED IN THE INCIDENT, OR OTHER INFORMATION OR CONCLUSIVE EVIDENCE RELATED TO THE CASE. 2024-04-02: UM SEARCHED IT SERVICE AND MAINTENANCE RECORDS AND IDENTIFIED TWO (2) SERVICE CALL THAT WERE ACTED UPON BY UM FOR PRODUCTS AT THE HCF, BETWEEN MAY AND JUNE 2023, BUT IS UNABLE TO CONFIRM WHETHER THEY ARE, IN ANY MANNER, RELATED TO THE BED. 2024-04-04: DURING A TELEPHONE CALL, THE CORONER INDICATED TO UM, THAT BASED ON INFORMATION PROVIDED BY THE HCF: A) THAT FOLLOWING THE INCIDENT, THE PERSONNEL OF THE HCF, WITH PRESUMABLY THE CONSENT OF THE FAMILY, DECIDED NOT TO PERFORM SURGERY ON THE PATIENT'S LEG AND TO PROVIDE ONLY COMFORT AND PALLIATIVE CARE AFTERWARDS SINCE PATIENT WAS ALREADY IN A DETERIORATING PHASE. B) THAT WHEN THE INCIDENT OCCURRED THE BED WAS IN A "HIGH POSITION", AND ONE (1) SIDERAIL HAD BEEN LOWERED BY THE HCF'S PERSONNEL (ALL OTHERS (3) SIDERAILS WERE IN A RAISED POSITION). C) THAT THE "BED EXIT DETECTION SYSTEM" OF THE BED HAD BEEN ACTIVATED AND RANG, AS INTENDED, WHEN THE INCIDENT OCCURRED (PATIENT EXITED THE BED). UM CONTACTED THE CORONER TO GET MORE INFORMATION ABOUT THE INCIDENT. 2024-04-09: UM CONTACTED THE CORONER WHO CONFIRMED THE EXACT DATES OF THE INCIDENT AND THE DEATH OF THE PATIENT. 2024-04-10 UNTIL TODAY: THE SERIAL NUMBER OF THE BED IS STILL UNCONFIRMED BY THE HCF, OR THE CORONER, AND UM IS LACKING ADDITIONAL INFORMATION TO COMPLETE ITS INVESTIGATION. THE CORONER'S REPORT WILL POSSIBLY CONFIRM, AT SOME POINT, THE EXACT CAUSE AND CIRCUMSTANCES RELATED TO THE INCIDENT. UM HAS NO REASON TO BELIEVE, AT THIS STAGE, THAT THERE WAS A DEFECT IN THE DESIGN OR FUNCTIONALITY OF THE BED THAT CAUSED THE INCIDENT. THE INCIDENT REMAINS PRESENTLY UNDER INVESTIGATION AND NO CONCLUSION CAN BE REACHED AT THE MOMENT.

    Additional Manufacturer Narrative · 0

    FOLLOWING THE SUBMISSION OF THE PRELIMINARY REPORT, UMANO MEDICAL RECEIVED WRITTEN COMMUNICATION FROM THE CORONER INDICATING THAT IT WAS NOT POSSIBLE TO CONCLUSIVELY IDENTIFY THE SPECIFIC DEVICE INVOLVED IN THE INCIDENT. CONSEQUENTLY, NO RECOMMENDATIONS WERE ISSUED CONCERNING ANY DEVICE MANUFACTURED OR DISTRIBUTED BY UMANO MEDICAL. NOTWITHSTANDING, THE CORONER DID NOTE DEFICIENCIES IN THE MANNER IN WHICH THE BED INVOLVED IN THE INCIDENT WAS MANAGED BY THE FACILITY'S PERSONNEL. THE CORONER INITIALLY ADVISED THAT A FINAL INVESTIGATION REPORT WOULD BE MADE AVAILABLE UPON COMPLETION OF INTERNAL REVIEW AND FORMAL APPROVAL. IN LIGHT OF THIS, UMANO MEDICAL DEFERRED THE CLOSURE OF ITS FINAL DECLARATION PENDING RECEIPT OF THE CORONER'S FINAL REPORT. DESPITE MULTIPLE FORMAL REQUESTS FOR ACCESS, ON JUNE 11, 2025, THE CORONER'S OFFICE CONFIRMED THAT THE FINAL REPORT COULD NOT BE DISCLOSED. THE INFORMATION AVAILABLE TO THE MANUFACTURER WAS DEEMED INSUFFICIENT TO IDENTIFY EITHER THE PATIENT OR THE SPECIFIC DEVICE INVOLVED, THEREBY PRECLUDING FURTHER ANALYSIS AND THE COMPLETION OF THE INVESTIGATION. BASED ON THIS OUTCOME, UMANO MEDICAL CONCLUDES THAT THERE IS NO EVIDENCE TO SUGGEST THAT ANY DEVICE MANUFACTURED OR DISTRIBUTED BY THE COMPANY MALFUNCTIONED OR CONTRIBUTED TO THE INCIDENT IN QUESTION.

    Description of Event or Problem · 0

    BASED ON A DISCLOSURE MADE ON 2024-04-02 ( "AWARENESS DATE") TO UMANO MEDICAL ("UM"), THAT IS PRESENTLY UNDOCUMENTED, AN ELDERLY PATIENT FELL OFF A BED MANUFACTURED BY UM (THE "BED") ON, OR AROUND, (B)(6) 2023 (THE "INCIDENT") AND BROKE HER LEG (IN TWO PLACES) AT THE HEALTH CARE FACILITY (THE "HCF"). THE PATIENT SUBSEQUENTLY DIED ON, OR AROUND, (B)(6) 2023 FOR A CAUSE THAT IS UNKNOWN, BUT THAT COULD BE RELATED TO THE INCIDENT. THE HCF CORONER CALLED UM ON AWARENESS DATE ASKING QUESTIONS REGARDING MANUFACTURER RECOMMENDATIONS ABOUT THE BED HEIGHT IN OPERATION. AT THE MOMENT OF THE INCIDENT, HCF CONFIRMED THAT: PATIENT WAS ALREADY IN A DETERIORATION PHASE PRIOR TO THE INCIDENT, THE BED WAS NOT AT THE LOWEST POSITION, ONE (1) SIDERAIL WAS LOWERED WHILE THE THREE (3) OTHERS WERE RAISED. THE BED EXIT DETECTION SYSTEM WAS ACTIVATED AND RANG AS INTENDED WHEN THE PATIENT EXITED THE BED. UM PRODUCT IDENTIFICATION (TRADE NAME, SERIAL NUMBER) ARE UNKNOWN AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919590 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL UMANO MEDICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death