BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HILL ROM, INC.

    MDR report key: 5369243 · Received January 4, 2016

    Report

    Report Number
    5369243
    Event Type
    Injury
    Date Received
    January 4, 2016
    Date of Event
    December 27, 2015
    Report Date
    December 29, 2015
    Manufacturer
    HILL-ROM
    Product Code
    IOQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BEING REPOSITION IN HILL-ROM BARIATRIC BED. BECAUSE OF PATIENT'S MORBID OBESITY, BED WAS PLACED IN TRENDELENBURG POSITION TO FACILITATE POSITIONING PATIENT UP IN BED. ONCE LIFT WAS COMPLETE, STAFF ATTEMPTED TO RETURN THE BED TO LEVEL, HOB INCREASED. BED WOULD NOT RESPOND TO PRESSING ON THE REVERSE TRENDELENBURG POSITION. STAFF NOTED THE BED HAD LOCKED ALL THREE (ELEVATION, HEAD AND KNEE GATCH) SETTINGS ON BEDRAIL. ATTEMPTS TO UNLOCK THE BED AS TRAINED UNSUCCESSFUL. HILL-ROM TECH AND HOSPITAL BIOMEDICAL ENGINEERING TECH CONSULTED. INSTRUCTIONS GIVEN WERE INEFFECTIVE. PILLOWS AND BLANKETS PLACED UNDER HEAD TO RAISE HOB TO FACILITATE BREATHING. AFTER THE POSITION CHANGE, BED UNLOCKED. BEDRAIL PLASTIC COVERING OF BUTTONS FOUND WITH BREACH OF INTEGRITY - THIS WAS THE CONTROL CENTER USED TO CHANGE THE BED'S POSITIONING. HILL-ROM NOTIFIED AND EXAMINED DEVICE ON SITE ON (B)(6) 2015. OUTCOME OF INSPECTION: ON MONDAY (B)(6) 2015 (B)(6), A FIELD SERVICE TECHNICIAN FROM HILL ROM WAS CALLED TO INSPECT THE TOTAL CARE BARIATRIC BED THAT WAS INVOLVED IN THE INCIDENT ON (B)(6) 2015. I INFORMED (B)(6) OF THE SEQUENCE OF EVENTS THAT OCCURRED, AND WHAT THE NURSES STATED HAPPENED TO THE BED. WE INSPECTED THE PATIENT RIGHT SIDE FOOT SIDE RAIL, SINCE THAT WAS THE SIDE THE NURSES WERE TRYING TO OPERATE THE BED FROM. DURING THE INSPECTION WE FOUND THAT THE BED CONTROL OVERLAY, OR LABEL, ON THE OUTSIDE OF THE SIDE RAIL HAD A SERIES OF CUTS IN IT. WE THEN INSPECTED THE INSIDE OF THE SIDE RAIL TO SEE IF THERE WAS ANY EVIDENCE OF A FOREIGN SUBSTANCE ON THE ELECTRICAL COMPONENTS. WE WERE UNABLE TO SEE IF THERE WAS ANY EVIDENCE OF A FOREIGN SUBSTANCE ON THE ELECTRICAL COMPONENTS. WE WERE UNABLE TO SEE ANY EVIDENCE OF ANY SUBSTANCE. (B)(6) WAS ALSO ABLE TO PULL THE LIST OF ERROR COMMANDS THAT WERE STORED IN THE BED. THE ERROR THAT WAS RECORDED ON (B)(6) 2015 WAS DUE TO A SCALE ISSUE (ERROR CODE 50-1-33-0-0-0). AFTER RUNNING THE BED THROUGH ALL THE NORMAL OPERATING FUNCTIONS, WE FOUND THAT THE BED WOULD NOT GO INTO "CHAIR POSITION". THIS PREVENTS THE FEET FROM LOWERING. THE BED IS CURRENTLY SEQUESTERED AND OUT OF SERVICE UNTIL FURTHER NOTICE. (B)(6) BIOMEDICAL ELECTRONIC TECHNICIAN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005 HILL ROM, INC. TOTAL CARE BARIATRIC IOQ HILL-ROM 1900-00

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening