BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2335618 · Received November 9, 2011

    Report

    Report Number
    1518293-2011-00214
    Event Type
    Malfunction
    Date Received
    November 9, 2011
    Date of Event
    October 19, 2011
    Report Date
    October 19, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) TROUBLESHOT AND FOUND AFTER INVESTIGATION THAT THE PRIMARY ISSUE WAS WITH THE VIDEO DISTRIBUTION BOX AND REPLACED THIS. FSE THEN NOTED THAT THE 12 V DC POWER SUPPLY WAS READING LOWER VOLTAGE THAN NORMAL AND REPLACED THE POWER SUPPLY. FSE THEN COMPLETED A CHECKOUT ODF THE UNIT FOR PROPER OPERATION PER HUT DR SERVICE CHECKLIST REFERENCING HUT DR SERVICE MANUAL. ALL READINGS WITHIN TOLERANCE AND THE SYSTEM WAS RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS THAT STAFF WERE PERFORMING AN UNDETERMINED UROLOGY PROCEDURE UNDER GENERAL ANESTHESIA WHEN BOTH SYSTEM TABLE MONITORS FAILED AND THE FLUORO IMAGE COULD NOT BE SEEN. STAFF TURNED THE CONTROL ROOM MONITOR TOWARDS THE CONTROL ROOM WINDOW AND PHYSICIAN COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT. CUSTOMER PROVIDED NO PT OR PROCEDURAL INFO OTHER THAN TO SAY THE PROCEDURE AND 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