BEUDAMED
    FDA Adverse Event Death Summary report: N

    HANA ORTHOPEDIC SURGERY TABLE

    MDR report key: 8132818 · Received December 5, 2018

    Report

    Report Number
    2921578-2018-00035
    Event Type
    Death
    Date Received
    December 5, 2018
    Date of Event
    November 8, 2018
    Report Date
    April 20, 2022
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    UDI-DI
    00842430108747
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RELEVANT INSTRUCTIONS IN THE OWNER'S MANUAL INCLUDE "WARNING: AFTER TRANSFERRING THE PATIENT TO THE TABLE, ASSIGN AT LEAST ONE ATTENDANT TO SUPPORT THE PATIENT UNTIL SAFELY SECURED TO THE TABLE WITH THE PATIENT SAFETY STRAP AND THE ASSOCIATED PERINEAL POST." AND "WARNING: WHEN THE PATIENT IS NO LONGER SECURED TO THE TABLE, ASSIGN AT LEAST ONE ATTENDANT TO SUPPORT THE PATIENT UNTIL SAFELY TRANSFERRED TO THE STRETCHER." INSERVICE TRAINING CONDUCTED 11/15/2018 AND 11/20/2018. THIS FOLLOW-UP REPORT DOCUMENTS ADDITIONAL INFORMATION RECEIVED ABOUT THE EVENT AND THE PATIENT OUTCOME.

    Description of Event or Problem · 0

    FOLLOWING SURGICAL REPAIR OF A BROKEN HIP, STAFF WERE PREPARING TO TRANSFER THE PATIENT FROM THE TABLE TO THE BED. SAFETY STRAP HAD NOT BEEN USED. PERINEAL POST WAS REMOVED. NO ONE WAS DIRECTLY ATTENDING TO THE PATIENT. HE BEGAN TO WAKE FROM THE ANESTHESIA, STARTED TO ROLL OVER, AND SLID OFF THE TABLE, STRIKING HIS HEAD ON THE FLOOR. CT SCAN REVEALED SUBDURAL HEMATOMA AND C2 VERTEBRAL FRACTURE. PATIENT WAS TRANSFERRED TO A TRAUMA CENTER WHERE A HALO VEST WAS PLACED. THE PATIENT DID NOT REGAIN CONSCIOUSNESS AND DEATH WAS ATTRIBUTED TO THE SPINAL FRACTURE.

    Additional Manufacturer Narrative · 1

    PREVENTIVE MAINTENANCE WAS COMPLETED ON 08/02/2018 AND 11/14/2018 AND THE TABLE PASSED THE INSPECTION. CONCLUSION OF INVESTIGATION IS OPERATOR ERROR OF NOT HAVING THE PATIENT SAFELY STRAPPED TO THE TABLE AND REMOVING THE PERINEAL POST PREMATURELY BEFORE TRANSFERRING PATIENT. TWO IN-SERVICE WERE PROVIDED 11/15/2018 & 11/20/2018 TO ENSURE THAT ALL STAFF MEMBERS WERE IN-SERVICED. THE OWNER'S MANUAL INCLUDES INSTRUCTIONS FOR SECURING THE PATIENT WITH A SAFETY STRAP.

    Description of Event or Problem · 1

    PATIENT FELL OFF TABLE - OUTCOME UNKNOWN. AS REPORTED, THE PATIENT SAFETY STRAP WAS NOT USED. WHEN PREPARING FOR PATIENT TRANSFER, THE PERINEAL POST WAS PULLED PREMATURELY AND THE PATIENT FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973119 HANA ORTHOPEDIC SURGERY TABLE OPERATING TABLE JEA MIZUHO OSI 6875 00842430108747

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Death