BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2480334 · Received February 28, 2012

    Report

    Report Number
    1518293-2012-00038
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 28, 2012
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    KQS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECH SUPPORT (TS) CONTACTED INFIMED SUPPORT FOR ASSISTANCE WITH BIOMED. INFIMED DETERMINED THAT THE FILE WAS CORRUPTED, AND ASSISTED IN GETTING THE PATIENT DATABASE ERROR CLEARED AND RECONNECTION MADE TO THE PATIENT DATABASE. BIOMED OPENED A TEST PATIENT AND VERIFIED THE FLUORO / DIGITAL SPOTS AND THE SYSTEM IS FULLY FUNCTIONAL. RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    (B)(6): CUSTOMER REPORTS VIA PHONE THAT STAFF WERE ATTEMPTING TO DO AN UNDETERMINED UROLOGY PROCEDURE WHEN THE SYSTEM FAILED AND THEY COULD NOT FLUORO. STAFF MOVED THE PATIENT TO ANOTHER ROOM WHERE THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT. CUSTOMER DID NOT PROVIDE PATIENT OR PROCEDURAL INFORMATION OTHER THAN TO SAY THE PATIENT IS FINE, PROCEDURE WAS COMPLETED. NO REPORTED INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK