BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS T2X OR TABLE V2 (ORT100)

    MDR report key: 7045130 · Received November 20, 2017

    Report

    Report Number
    7045130
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Report Date
    November 3, 2017
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IMRIS OR MRI BED SPONTANEOUSLY MOVED 10 DEGREES FROM LEVELED PLANE AT 90 DEGREES. MANUFACTURER RESPONSE FOR HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP), CLEARPOINT (PER SITE REPORTER): CUSTOMER SERVICE ENGINEER WAS NOTIFIED AND REP EVALUATED BED AND DISCOVERED ISSUE WITH HYDRAULIC MANIFOLD. PARTS HAVE BEEN ORDERED, BED AND OR SUITE REMAIN OUT OF SERVICE.

    Description of Event or Problem · 1

    IMRIS OR MRI BED SPONTANEOUSLY MOVED 10 DEGREES FROM LEVELED PLANE AT 90 DEGREES. MANUFACTURER RESPONSE FOR HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP), CLEARPOINT (PER SITE REPORTER): CUSTOMER SERVICE ENGINEER WAS NOTIFIED AND REP EVALUATED BED AND DISCOVERED ISSUE WITH HYDRAULIC MANIFOLD. PARTS HAVE BEEN ORDERED, BED AND OR SUITE REMAIN OUT OF SERVICE.

    Description of Event or Problem · 1

    IMRIS OR MRI BED SPONTANEOUSLY MOVED 10 DEGREES FROM LEVELED PLANE AT 90 DEGREES. MANUFACTURER RESPONSE FOR HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP), CLEARPOINT (PER SITE REPORTER): CUSTOMER SERVICE ENGINEER WAS NOTIFIED AND REP EVALUATED BED AND DISCOVERED ISSUE WITH HYDRAULIC MANIFOLD. PARTS HAVE BEEN ORDERED, BED AND OR SUITE REMAIN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826194 IMRIS T2X OR TABLE V2 (ORT100) TABLE, OPERATING-ROOM, AC-POWERED FQO IMRIS - DEERFIELD IMAGING, INC. ORT100

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR