BEUDAMED
    FDA Adverse Event Summary report: N

    HANA ORTHOPEDIC SURGERY TABLE

    MDR report key: 3786113 · Received April 28, 2014

    Report

    Report Number
    3786113
    Date Received
    April 28, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MIZUHO OSI MEDICAL CO. LTD
    Product Code
    JEA
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE POST SURGICAL PATIENT WAS ON A HANA ORTHOPEDIC SURGERY TABLE WITH LEFT FOOT IN BOOT ATTACHED TO SPAR, RIGHT LEG FLEXED AND IN LEG POSITIONER, POST IN PLACE BETWEEN LEGS, LEFT ARM ABDUCTED ACROSS CHEST (HELD WITH STOCKINETTE WRAPPED AROUND THE BED). NO ARM BOARD ON LEFT SIDE DUE TO POSITIONING. PER THE SURGICAL STAFF, NO SAFETY STRAP WAS USED AS THE PATIENT WAS PREPPED TO THE LOWER RIB CAGE AND THE STRAP WOULD BE IN THE WAY IF USED AROUND THE SPAR OR ACROSS THE NECK IF ABLE TO GET ON THE SIDE RAIL. OCCASIONALLY THE STRAP IS USED ON ARM BOARD IN OTHER CASES, BUT UNABLE TO USE AN ARM BOARD FOR THIS SURGERY. IN PREPARATION TO TRANSFER THE PATIENT TO A CART, THE DRAPES WERE REMOVED. THE LOWER PART OF HANA TABLE (FEMORAL ASSISTANT/USED FOR TRANSFERS) WAS INSERTED SO THE PATIENT'S LEGS COULD BE MOVED OUT OF THE POSITIONERS. STAFF WERE FOCUSED ON INDIVIDUAL TASKS IN PREPARATION TO TRANSFER THE PATIENT FROM THE HANA TABLE TO A BED WHEN THE PATIENT FELL APPROXIMATELY 3-4 FEET OFF THE HANA TABLE ONTO THE FLOOR. (THE BED HAD BEEN LOWERED FROM SURGICAL HEIGHT.) THERE WAS NO INJURY TO THE PATIENT OR STAFF. FINDINGS: THERE IS AN INCONSISTENT PRACTICE OF NOT HAVING THE PATIENT SAFETY STRAP APPLIED TO PATIENTS ON THE HANA BED. THE PLAN IS TO EDUCATE THAT THE SAFETY STRAP CAN BE PUT ON AT THE BEGINNING OF THE CASE. TO PREVENT THE PATIENT STRAP FROM GOING ACROSS THE PATIENT'S NECK OR THE SURGICAL SITE, STAFF WERE INSTRUCTED TO APPLY THE STRAP AS LOW AS POSSIBLE WITHOUT IMPEDING THE SURGICAL FIELD AND TO WRAP THE STRAP ALL THE WAY AROUND THE TABLE AND THE STRAP HOOKS TO ITSELF (AS THERE IS NO FOUNDATION AS ON OTHER BEDS). ALSO, WE WILL EXPLORE OTHER SAFETY STRAP OPTIONS. THE DESIGN OF THE HANA BED MAKES USE OF THE PATIENT SAFETY STRAP CHALLENGING. THE PATIENT SAFETY STRAP MUST BE PLACED CAREFULLY (TOO HIGH IS A CHOKING RISK AND TOO LOW AND IT IS IN THE SURGICAL FIELD) AND IT CANNOT BE CLAMPED ON THE BED'S SIDE RAILS.WE WOULD LIKE THE MANUFACTURER TO NOTE THAT THE PATIENT SAFETY STRAP IS LISTED AS ONE OF THE COMPONENTS IN THE HANA'S OPERATIONAL MANUAL; HOWEVER, THERE ARE NO PHOTOGRAPHS/DIAGRAMS IN THE MANUAL TO DEMONSTRATE/EXPLAIN WHERE/HOW TO PLACE THE SAFETY STRAP ON THE PATIENT. WE RECOMMEND THAT THE MANUFACTURER INCLUDE PHOTOS/DIAGRAMS OF THE PLACEMENT AND POSITIONING OF THE PATIENT SAFETY STRAP IN THE OPERATIONAL MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253378 HANA ORTHOPEDIC SURGERY TABLE TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED JEA MIZUHO OSI MEDICAL CO. LTD 6875 *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR
    2 *