BEUDAMED
    FDA Adverse Event Other Summary report: N

    BUTTON ACTUATOR

    MDR report key: 2208809 · Received July 19, 2011

    Report

    Report Number
    2126677-2011-00118
    Event Type
    Other
    Date Received
    July 19, 2011
    Date of Event
    June 3, 2011
    Report Date
    July 19, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A 510 (K) CAN NOT BE DETERMINED WITHOUT A DEVICE NAME OR SERIAL NUMBER. MANUFACTURE DATE CAN NOT BE DETERMINED WITHOUT A SERIAL NUMBER. (B)(4). THE REPORTER DOES WANT THEIR IDENTITY DISCLOSED.

    Description of Event or Problem · 1

    GE HEALTHCARE RECEIVED A COPY OF THE ATTACHED MEDWATCH 3500 FORM FROM THE REPORTING FACILITY ON (B)(6) 2011. PER THE MEDWATCH REPORT, "1 DAY OLD NEWBORN WITH HISTORY OF SHOULDER DYSTOCIA, CLAVICLE X-RAY ORDERED TO RULE OUT FRACTURE, RESULTS NEGATIVE. AS REPORTED X-RAY TECHNICIAN POSITIONED PATIENT AND TURNED AWAY FOR THE TECHNIQUE, WHEN HE SAW THE X-RAY TUBE MOVING DOWN ON THE PATIENT. TECH CAUGHT THE TUBE COLUMN BUT WAS UNABLE TO PREVENT IT FROM COMPLETELY COMING IN CONTACT WITH THE INFANT. PATIENTS MEDICAL DOCTOR NOTIFIED, PHYSICAL EXAM, KUB AND CHEST X-RAY PERFORMED AND REPORTED TO BE WITHIN NORMAL LIMITS. INFANT KEPT UNDER OBSERVATION FOR AN EXTRA DAY BEFORE DISCHARGED. GE PORTABLE EVALUATED, INTERNAL HANDLE ACTUATOR PLATE HAD A BROKEN TAB WHICH CAUSED THE PLATE TO TWIST AND STICK IN A POSITION THAT KEPT THE BRAKE DISENGAGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUTTON ACTUATOR PORTABLE X-RAY IZL GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Hospitalization