BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1993886 · Received January 13, 2011

    Report

    Report Number
    1518293-2010-00178
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SVC ENGINEER FOUND THE INFIMED COMPUTER KEYBOARD FAILED AT START UP AND WOULD NOT ACCEPT ANY NUMBERS OR LETTERS PRESSED AS ANY INPUT TO THE SYS. WHEN THE KEYBOARD FAILED, SYS WOULD NOT ADVANCE TO FLUORO STAGE. FSE REMOVED THE KEYBOARD AND REPLACED IT WITH KEYBOARD REPLACEMENT KIT, PN 710271 AND TESTED UNIT AS PER HUT DR SVC CHECKLIST. SYS PASSED ALL SVC TESTS AND WAS RETURNED TO FULL SVC BY THE CUSTOMER. KEYBOARD WAS RETURNED TO COVIDIEN. LOGITECH P/N 868026-0403, SERIAL # (B)(4). IT WAS TESTED IN THE RELIABILITY LAB ON (B)(4) 2011, AND ALL FUNCTIONS APPEARED NORMAL. IT WAS INSTALLED ON A LAB HP TOWER PC, WHICH BOOTED NORMALLY. ALL KEYS WERE TESTED AND FUNCTIONED WITHOUT ISSUE, INCLUDING THE KEYPAD, NUMLOCK AND CAPS LOCK KEYS. IT IS UNCLEAR WHAT MAY HAVE CAUSED THE ISSUE DESCRIBED.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS MALE PT HAVING A RETROGRADE PYELOGRAM PROCEDURE WHEN SYS FLUORO FAILED. STAFF BROUGHT IN A PORTABLE C-ARM FLUORO UNIT AND PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO REPORTED INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK