BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 4110719 · Received September 16, 2014

    Report

    Report Number
    1518293-2014-00110
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECH SUPPORT ASSISTED BIOMED WHO REPORTED THE COLLIMATOR WOULD INTERMITTENTLY JAM GIVING AN ERROR. BIOMED SAID HE HAD RECEIVED THE NEW COLLIMATOR AND NEEDED ASSISTANCE WITH CONFIGURING AND CALIBRATING THE NEW PART. ON FINAL CALLBACK, BIOMED SAID COLLIMATOR WAS INSTALLED, CONFIGURED, AND CALIBRATED, AND SYSTEM WAS BACK IN SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE THAT DURING AN UNDETERMINED UROLOGY PROCEDURE, THE SYSTEM COLLIMATOR FAILED, AND LOCKED OUT FLUORO. STAFF MOVED THE PATIENT TO ANOTHER ROOM, WHERE THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT. CUSTOMER DID NOT PROVIDE FURTHER PATIENT OR PROCEDURAL INFORMATION, OTHER THAN TO SAY THE PATIENT IS FINE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572027 HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL FLARSHEIM HUT EXT DR FINAL A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK