BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM 3RD EDITION

    MDR report key: 4133658 · Received October 1, 2014

    Report

    Report Number
    1723170-2014-01041
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 2, 2014
    Report Date
    August 24, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K092564
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RMA ISSUED. REPLACEMENT 8-PACK BATTERY KIT, 6-PACK BATTERY KIT AND DIODE CABLE SHIPPED TO SITE (B)(4) 2014. SUSPECT DIODE CABLE RETURNED ON (B)(4) 2014. BATTERY KITS HAVE NOT BEEN RETURNED TO MANUFACTURER FOR ANALYSIS. - (B)(4) 2014, A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED DIODE ON BATTERY TRAY 1 APPEARS TO BE BLOWN. - (B)(4) 2014, A MEDTRONIC REPRESENTATIVE PERFORMED AN IMAGING SYSTEM CHECK-OUT. REPLACED DIODE ON BATTERY TRAY ONE AND ALL SIX BATTERIES IN THE TRAY. TESTED SYSTEM, READY FOR USE. SYSTEM PERFORMED AS INTENDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE SUSPECT DIODE CABLE ASSEMBLY CONFIRMED THE REPORTED PROBLEM. THE DIODE BURNT DUE TO ELECTRICAL OVER STRESS. LOW RESISTANCE ACROSS DIODE 200 OHMS.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT FROM A SITE THAT ON THE PREVIOUS DAY THERE WAS A BURNING SMELL COMING FROM THEIR O-ARM 1000 IMAGING SYSTEM. THE SITE STATED THEY USED THE SYSTEM FOR PROCEDURES NORMALLY. NO FURTHER DETAILS WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611537 O-ARM 1000 IMAGING SYSTEM 3RD EDITION IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00028-120

    Patients

    Seq Age Sex Outcome Treatment
    1