BEUDAMED
    FDA Adverse Event Other Summary report: N

    6850 PROFX DEVICE #1

    MDR report key: 1637712 · Received March 12, 2010

    Report

    Report Number
    2921578-2010-00002
    Event Type
    Other
    Date Received
    March 12, 2010
    Date of Event
    February 10, 2010
    Report Date
    March 8, 2010
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TABLE DID NOT BURN; HOWEVER, THE CONTROLLER AND STEPPER MOTOR OVERHEATED CAUSING A BURNING SMELL. THE SMELL CAUSED THE NURSE TO PULL THE FIRE ALARM. THE HOSPITAL'S BIOMEDICAL ENGINEER (B)(6) STATED THAT THE NURSE OVER REACTED AND SHOULD HAVE JUST TURNED THE TABLE OFF AND REMOVED THE TABLE FROM THE OPERATING ROOM. THE TABLE HAS BEEN FIXED AND IS CURRENTLY IN USE AT THE HOSPITAL. THE STEPPER MOTOR CONTROLLER AND BRAKE MOTOR CAUSED THE SMELL AND STOPPED WORKING. AFTER REPLACEMENT OF THE BRAKES AND MOTOR CONTROLLER AND THE TABLE WAS FULLY OPERATIONAL. (B)(4) 2010.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE TABLE WAS NOT FUNCTIONING AND BEGAN SMOKING. NURSE PULLED FIRE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6850 PROFX DEVICE #1 OPERATING ROOM TABLE JEB MIZUHO ORTHOPEDIC SYSTEMS, INC. 6850

    Patients

    Seq Age Sex Outcome Treatment
    1 Other