BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAUSTED MBC CHAIR

    MDR report key: 10015525 · Received April 30, 2020

    Report

    Report Number
    1043572-2020-00023
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Date of Event
    February 12, 2020
    Report Date
    April 30, 2020
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    INM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A THIRD-PARTY SERVICE PROVIDER ARRIVED ONSITE TO INSPECT THE HAUSTED MBC CHAIR AND FOUND THAT THE BRAKE PAD HAD SPLIT. THE DAMAGE TO THE BRAKE PAD ALLOWED THE BRAKE TO UNLOCK RESULTING IN THE REPORTED EVENT. THE CHAIR WAS INSTALLED AT THE USER FACILITY IN 2002 MAKING IT APPROXIMATELY 18 YEARS OLD. THE THIRD-PARTY SERVICE PROVIDER REPLACED THE BRAKE PAD, TESTED THE CHAIR, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATIONS AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED VIA VIGILANCE REPORT NUMBER 2020/003/005/401/016 THAT DURING A PATIENT PROCEDURE THEIR HAUSTED MBC CHAIR BEGAN SLIDING FROM THE INTENDED POSITION. THE PATIENT WAS REPOSITIONED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476356 HAUSTED MBC CHAIR CHAIR INM STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1