BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 4222975 · Received November 4, 2014

    Report

    Report Number
    1518293-2014-00136
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) INVESTIGATED REPORT THAT THE GENERATOR CONSOLE INTERMITTENTLY CUTS OFF (BLANK) AND REPLACED THE SEDECAL GENERATOR CONSOLE. FSE VERIFIED CONFIGURATION AND CHECKED FOR PROPER FUNCTION PER SERVICE CHECKLIST AND RETURNED UNIT TO FULL SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE, THEY REMEMBER THE SYSTEM FLUORO FAILED, BUT THEY HAVE NO INFORMATION TO PROVIDE, OTHER THAN TO SAY THEY KNOW THE PATIENT IS FINE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707414 HUT EXT DR FINAL ASSY-STANDARD IXR IXR LIEBEL FLARSHEIM

    Patients

    Seq Age Sex Outcome Treatment
    1