BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 3193192 · Received June 25, 2013

    Report

    Report Number
    1518293-2013-00147
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 25, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) TROUBLESHOT A COLLIMATOR POWER COMPLAINT AND FOUND A BURNT CONNECTOR ON THE 24 VAC INCOMING POWER WIRE THAT CONNECTS TO THE LOCKS BOARD. FSE REPAIRED THE CONNECTIONS AND VERIFIED PROPER OPERATION USING HUT DR SERVICE MANUAL 4041004, SEDECAL GENERATOR SERVICE MANUAL 710953, HUESTIS COLLIMATOR SERVICE MANUAL 710951, AND THE INFIMED PLATINUM ONE TECH MANUAL 710273. FSE CHECKED SYSTEM PER SERVICE CHECKLIST QSSRI4.1 AND RETURNED THE UNIT TO CUSTOMER FOR SERVICE.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS VIA PHONE THAT DURING A BILATERAL RETROGRADE PROCEDURE ON A MALE (AGE UNK), THE SYSTEM FLUORO FAILED. PHYSICIAN COMPLETED THE PROCEDURE USING ENDOSCOPY WITHOUT FURTHER INCIDENT. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287239 HUT EXT DR FINAL ASSY-STANDARD IXR LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK