BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED CONTROL I-BASE, DC

    MDR report key: 14876899 · Received June 30, 2022

    Report

    Report Number
    2921578-2022-00011
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    May 24, 2022
    Report Date
    August 31, 2022
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    UDI-DI
    00842430106026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION RECEIVED FROM THE INCIDENT INVESTIGATION, IT WAS FOUND OUT THAT THE BRAKE LOCKS OF THE TABLE THAT ARE SUPPOSED TO HOLD THE PATIENT WERE UNKNOWIGLY LEFT RELEASED BY THE HOSPITAL PERSONNEL WHICH LED TO THE TILTING OF THE TABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ROTATION LOCK OF THE SURGERY TABLE WAS NOT HOLDING WHICH CAUSED THE TABLE TO TILT WITH PATIENT ON IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ROTATION LOCK OF THE SURGERY TABLE WAS NOT HOLDING WHICH CAUSED THE TABLE TO TILT WITH PATIENT ON IT. THE X-RAY TECH WAS NEXT TO THE PATIENT AND NOTICED THE TABLE WAS ROLLING (TILTING) AND CAUGHT THE TABLE TOP AND PATIENT AND GENTLY ROLLED HIM TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2397467 ADVANCED CONTROL I-BASE, DC OPERATING TABLE JEA MIZUHO OSI 5803 00842430106026

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other