BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 3770668 · Received April 24, 2014

    Report

    Report Number
    1723170-2014-00408
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PER FURTHER REVIEW, IT WAS FOUND THAT THIS EVENT DID NOT MEET THE DEFINITION OF SERIOUS INJURY AS IT WAS A MINOR INJURY (ELECTRIC SHOCK) THAT DID NOT REQUIRE MEDICAL TREATMENT. ADVERSE EVENT/SERIOUS INJURY INADVERTENTLY SELECTED ON THE INITIAL 3500A, CORRECTED TO PRODUCT PROBLEM/MALFUNCTION.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION PROVIDED IS OF THE USER INVOLVED IN THIS EVENT AND NOT A PATIENT AS NO PATIENT WAS INVOLVED IN THIS CONCERN. OTHER SERIOUS: ELECTRIC SHOCK. NO LONG TERM EFFECTS ON THE USER AND NO MEDICAL INTERVENTION WAS REQUIRED. PATIENT CODE RELATES TO THE USER INVOLVED IN THIS EVENT AND NOT A PATIENT AS NO PATIENT WAS INVOLVED IN THIS CONCERN. THE MEDTRONIC REPRESENTATIVE WAS SHOCKED AS THE SITE HAD PLUGGED THE SYSTEM INTO THE WALL WITHOUT ALERTING THE MEDTRONIC REPRESENTATIVE. THE INCIDENT WAS CAUSED BY USER ERROR. A MEDTRONIC REPRESENTATIVE REPLACED THE FUSES ON IMAGING SYSTEM AND PERFORMED A NAVIGATION SYSTEM CHECK-OUT WHICH SHOWED ALL AREAS PASSED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE IMAGING SYSTEM LOST POWER DURING TRANSPORT OF THE SYSTEM AND COULD NOT BE POWERED BACK ON. WHILE THE MEDTRONIC REPRESENTATIVE WAS REPLACING THE FUSES ON THE IMAGING SYSTEM, THE MEDTRONIC REPRESENTATIVE WAS ELECTRICALLY SHOCKED. THE MEDTRONIC REPRESENTATIVE DID NOT REQUIRE MEDICAL TREATMENT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248981 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00027-120

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other