BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIUM DUTY DUAL YOKE

    MDR report key: 5447139 · Received February 19, 2016

    Report

    Report Number
    0002031963-2016-00002
    Event Type
    Injury
    Date Received
    February 19, 2016
    Date of Event
    January 22, 2016
    Report Date
    April 20, 2020
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT CODE FOR THE INITIAL FILING WAS FILED INCORRECTLY. THIS RECORD HAS BEEN UPDATED TO REFLECT THE CORRECT PRODUCT CODE OF FQO.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT IN GI ROOM 7 THE MEDIUM DUTY SUSPENSION WITH DUAL FLAT PANEL MONITOR (DFPM) ALLEGEDLY DRIFTED. REPORTEDLY, THE NURSE HIT THE DFPM UPON STANDING UP AFTER BENDING OVER TO PICK SOMETHING UP OFF OF THE FLOOR. ALLEGEDLY, THE NURSE HAD SIGNIFICANT HEAD PAIN AND WAS SEEN IN THE EMERGENCY DEPARTMENT. IT WAS REPORTED THAT THE EMERGENCY DEPARTMENT PERFORMED A NEURO ASSESSMENT. THE NURSE PASSED THE ASSESSMENT AND WAS DISCHARGED. THE NURSE REPORTEDLY RETURNED TO THE EMERGENCY DEPARTMENT TWO DAYS LATER TO BE REASSESSED AS SHE REPORTED COMPLAINTS OF A SEVERE HEADACHE AND VOMITING. THE EMERGENCY DEPARTMENT PERFORMED A CT SCAN ON HER HEAD, WHICH WAS NEGATIVE. AFTER FURTHER INVESTIGATION, A STRYKER FIELD SERVICE TECHNICIAN (SFST) PERFORMED A ROTATION TEST AS WELL AS A SPRING ARM ARTICULATION TEST AND WAS UNABLE TO DUPLICATE THE COMPLAINT. THERE WAS NO CONFIRMED MALFUNCTION OF THE DEVICE AND NO CONFIRMATION OF PERMANENT IMPAIRMENT OR DAMAGE TO THE USER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN GI ROOM 7 THE DUAL FLAT PANEL MONITOR (DFP) ALLEGEDLY DRIFTED AND THAT A NURSE HIT THE DFP UPON STANDING AFTER BENDING OVER TO PICK SOMETHING OFF OF THE FLOOR. SHE REPORTED TO HAVE SIGNIFICANT HEAD PAIN AND WENT TO THEIR EMERGENCY DEPARTMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN GI ROOM 7 THE DUAL FLAT PANEL MONITOR (DFP) ALLEGEDLY DRIFTED AND THAT A NURSE HIT THE DFP UPON STANDING AFTER BENDING OVER TO PICK SOMETHING OFF OF THE FLOOR. SHE REPORTED TO HAVE SIGNIFICANT HEAD PAIN AND WENT TO THEIR EMERGENCY DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104513 MEDIUM DUTY DUAL YOKE MEDIUM DUTY DUAL YOKE FQO BERCHTOLD GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1