BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 2102923 · Received May 4, 2011

    Report

    Report Number
    1518293-2011-00079
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER TROUBLESHOT PER SERVICE MANUAL AND FOUND NO POWER (25 VAC) AT THE COLLIMATOR AND TRACED IT BACK TO THE LOCKS COLLIMATOR PCB. FSE FOUND THE 250V 10 AMP SLOW BLOW FUSE WAS OPEN AND REPLACED THE FUSE. COLLIMATOR THEN POWERED BACK UP. FSE WAS NOT ABLE TO DETERMINE CAUSE OF OPEN FUSE. FSE VERIFIED PROPER OPERATION PER OF SYSTEM PER HYDRADJUST DR SYSTEM SERVICE CHECKLIST. SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS THAT A MALE WAS UNDERGOING A STONE EXTRACTION WITH STENT PLACEMENT PROCEDURE WHEN FLUORO AND RAD IMAGING FAILED. PHYSICIAN HAD JUST PLACED STENT; PORTABLE X-RAY IMAGES WERE TAKEN TO DOCUMENT. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUT EXT DR FINAL ASSY-STANDARD UROLOGY SUITE KQS LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK