BEUDAMED
    FDA Adverse Event Other Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 1744610 · Received June 22, 2010

    Report

    Report Number
    1723170-2010-00032
    Event Type
    Other
    Date Received
    June 22, 2010
    Date of Event
    May 24, 2010
    Report Date
    May 24, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    IZL
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT AVAILABLE FOR EITHER PATIENT BUT HAS BEEN REQUESTED; THE CABLE ASSEMBLY WAS EVALUATED BY THE MANUFACTURER ON (B)(4) 2010. THE FAILURE MODE WAS CONFIRMED AND WAS SIMILAR TO RESULTS OBSERVED DURING ACCELERATED LIFE TESTING OF THE PRODUCT. CUSTOMER USAGE INDICATES THAT THE USEFUL LIFE OF THE CABLE MAY HAVE BEEN EXCEEDED. THE CURRENT USER MANUAL RECOMMENDS A VISUAL INSPECTION AND FUNCTIONALITY CHECK OF THE CABLE ON A PERIODIC BASIS.

    Description of Event or Problem · 1

    USER REPORTED THE CABLE TO OPEN THE O-ARM WAS BROKEN AND THEY COULD NOT REMOVE THE O-ARM FROM AROUND THE PATIENT. THERE WAS NO ADVERSE EVENT TO THE PATIENT. THE OPERATING TABLE WAS DISMANTLED AND PATIENT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O-ARM 1000 IMAGING SYSTEM MOBILE X-RAY SYSTEM (IZL) IZL MEDTRONIC NAVIGATION BI-700-00027 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK