BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 11999937 · Received June 15, 2021

    Report

    Report Number
    3006544299-2021-00262
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    June 14, 2021
    Report Date
    June 15, 2021
    Manufacturer
    SANMINA -SCI SYSTEMS
    Product Code
    OWB
    UDI-DI
    00763000132378
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT A CONSTANT E011 ERROR IN GENERATOR CAUSED THE BEEPING SOUND. A FUSE BLOWN ON THE POWER TRAY AND THE GFI CIRCUIT TRIPPED IN THE CHARGER ENCLOSURE. THE FUSE WAS REPLACED IN TROUBLESHOOTING AND GFI CIRCUITRY WAS RESET. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING THE IMAGING SYSTEM. IT WAS REPORTED THAT OUTSIDE OF A PROCEDURE THAT AFTER POWERING ON THE SYSTEM IT WAS CONTINUOUSLY BEEPING. THE IMAGE ACQUISITION SYSTEM (IAS) SHOWED ALL RED X'S FOR THE INITIALIZATION. THE SITE REBOOTED MULTIPLE TIMES WITH NO CHANGE. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897998 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SANMINA -SCI SYSTEMS BI70002000 00763000132378

    Patients

    Seq Age Sex Outcome Treatment
    1