BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FONAR 360

    MDR report key: 3873727 · Received February 6, 2014

    Report

    Report Number
    2432211-2014-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Date of Event
    January 8, 2014
    Report Date
    February 6, 2014
    Manufacturer
    FONAR CORP.
    Product Code
    LNH
    PMA / PMN Number
    K994287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DESCRIBED HEADACHE AND SHOULDER PAIN. PATIENT WAS SEEN BY THE DUTY DOCTOR AT THE TIME AND WAS DECLARED FIT TO GO HOME. PATIENT CONTACTED ON (B)(6) 2014 FOR AN UPDATE AND HER SYMPTOMS HAD RESOLVED. TWO STAFF MEMBERS WERE ALSO AFFECTED. FIRST, THE RADIOGRAPHER, WHO IS OFF SICK DUE TO A MUSCLE INJURY DIRECTLY RESULTING FROM TAKING THE MAJORITY OF THE WEIGHT OF THE TABLE AND PATIENT (APPROXIMATELY (B)(6) KG). SECOND, A CLINICAL SUPPORT WORKER HAD INITIAL COMPLAINTS OF HIP AND BACK PAIN BUT HAS SINCE RETURNED TO WORK. REFERENCE NO.: (B)(4).

    Description of Event or Problem · 1

    WHILE MOVING THE BED OUT TO UNLOAD A PATIENT AT THE CONCLUSION OF A SCAN, ONE OF THE RAILS OF THE PORTABLE HORIZONTAL FOUR-LEGGED PATIENT TABLE DETACHED AND ONE SIDE OF THE BED, WHICH WAS NO LONGER SUPPORTED, FELL TO THE FLOOR WITH THE PATIENT. THE RADIOGRAPHER TRIED TO SUPPORT THE BED TO LESSEN THE FORCE OF THE FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77527 FONAR 360 MAGNETIC RESONANCE IMAGING SCANNER LNH FONAR CORP. FONAR 360 0.6 TESLA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other