BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLE, HANA, 110 V

    MDR report key: 15189157 · Received August 8, 2022

    Report

    Report Number
    2921578-2022-00013
    Event Type
    Injury
    Date Received
    August 8, 2022
    Date of Event
    August 4, 2022
    Report Date
    September 15, 2022
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    UDI-DI
    00842430108747
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION RECEIVED FROM THE INVESTIGATION, THE PATIENT WAS SECURED USING 3-INCH SILK TAPE AND NOT THE SAFETY STRAP AS MENTIONED IN THE INSTRUCTIONS FOR USE THAT MIGHT HAVE CONTRIBUTED TO THE PATIENT FALL. DEVICE EVALUATION BY THE FIELD SERVICE ENGINEER AND HOSPITAL PERSONNEL COULD NOT REPRODUCE THE PROBLEM AS INITIALLY REPORTED. ON (B)(6) 2022 IT WAS REPORTED TO MIZUHO OSI THAT THE PATIENT DIED ONE WEEK AFTER THE SURGERY ON (B)(6) 2022. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. IT IS UNKNOWN IF THE OPERATING ROOM FALL MAY HAVE CONTRIBUTED TO THE PATIENT DEATH, OR IF IT WAS DUE TO THE BROKEN BONE AND SURGERY ON TOP OF THE PATIENT'S ALREADY FRAGILE CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TOP OF THE TABLE MOVED 2 PLUS INCHES IN AN AIRPLANE FASHION DURING SURGERY. THE PATIENT FELL OFF THE BED AND SUSTAINED INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TOP OF THE TABLE MOVED 2 PLUS INCHES IN AN AIRPLANE FASHION DURING SURGERY. THE PATIENT FELL OFF THE BED AND SUSTAINED INJURY. PATIENT RECEIVED A LACERATION ON THE HEAD WHICH WAS CLEANED AND DRESSED. NO STITCHES WERE NEEDED. CT SCANNING WAS DONE FROM HEAD ON DOWN. THE ONLY ADDITIONAL INJURY FOUND WAS A POSSIBLE FRACTURE AT L1. PATIENT PASSED AWAY ONE WEEK AFTER THE SURGERY ((B)(6) 2022) AND IT WAS REPORTED TO MIZUHO OSI ON (B)(6) 2022. MEDICAL STATUS OF THE PATIENT PRIOR TO INCIDENT: THE PATIENT HAD A LENGTHY MEDICAL HISTORY INCLUDING CARDIOVASCULAR DISEASE, ALZHEIMER'S AND PREVIOUS FALLS. THE FEMORAL INJURY HAPPENED IN A FALL AT HOME FOR WHICH THE PATIENT WAS BEING OPERATED FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2346654 TABLE, HANA, 110 V OPERATING TABLE JEA MIZUHO OSI 6875 00842430108747

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Other| D| H| R