BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION CT

    MDR report key: 11649455 · Received April 12, 2021

    Report

    Report Number
    2126677-2021-00039
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Report Date
    April 12, 2021
    Product Code
    JAK
    PMA / PMN Number
    K163213
    Removal / Correction Number
    GEHC REF# 25496
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LEGAL MANUFACTURER: (B)(4). GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806. GEHC REF#: (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION THAT THE TABLE PINCH PROTECTOR MAY HAVE COME OFF LEAVING STANDING FLAT-HEAD SCREWS. THERE WAS NO INJURY INVOLVED WITH THIS MALFUNCTION EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545051 REVOLUTION CT COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK CSRV12

    Patients

    Seq Age Sex Outcome Treatment
    1