BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 7824656 · Received August 28, 2018

    Report

    Report Number
    1723170-2018-04289
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Date of Event
    August 3, 2018
    Report Date
    September 12, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OWB
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT SYSTEM FUNCTIONING NORMALLY. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT PROVIDED DUE TO (B)(6) PATIENT PRIVACY REGULATIONS. NO PARTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. IT WAS REPORTED THAT INTRA/PERI-OPERATIVELY DURING THE SELECT PATIENT/ACQUIRE SCANS TASK OF A PROCEDURE, ALTHOUGH THE SYSTEM WAS CHANGED FROM THE SHAPE OF C TO THE SHAPE OF O, THE INDICATION OF ¿DOOR OPEN¿ DID NOT DISAPPEAR. THE ISSUE WAS RESOLVED SOMEHOW AND IMAGES WERE TAKEN. IN ADDITION, WHEN THE SYSTEM WAS CHANGED FROM THE SHAPE OF C TO THE SHAPE OF O, AN ABNORMAL SOUND WAS HEARD. THERE WAS A DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664527 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (LITTLETON)

    Patients

    Seq Age Sex Outcome Treatment
    1