BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2102225 · Received May 17, 2011

    Report

    Report Number
    1518293-2011-00094
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER, ON SITE FOR ANOTHER UNRELATED ISSUE HAD NOTICED THAT THE LEG EXTENSION WAS NOT PROPERLY INSERTED AND HAD SHOWN THE STAFF HOW TO INSERT THE EXTENSION CORRECTLY. FSE, THEN AS PART OF THE SYSTEM CHECKOUT, VERIFIED THE FUNCTION OF ALL HYDRAULIC MOTIONS, THE TABLE ACCESSORY SENSOR, AND THE LEG EXTENSION LATCH ACCORDING TO HUT DR SERVICE MANUAL WITH NO PROBLEMS FOUND. THIS UNIT WAS RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS THAT DURING A UROLOGY PROCEDURE, THE STAFF HAD PLACED THE 24 INCH LEG EXTENSION ON THE TABLE, THEN ATTEMPTED TO ALSO ATTACH THE SMALLER EXTENSION TO THE EXISTING EXTENSION. WHEN THE STAFF ATTEMPTED THIS, THE 24 INCH EXTENSION DETACHED FROM THE TABLE, FALLING AND HITTING THE STAFF MEMBER ON THE SHIN. THE STAFF MEMBER WAS SENT TO THE ER FOR TREATMENT, WHERE THE PHYSICIANS DETERMINED THE STAFF HAD A BRUISED BONE. THERE WERE NO LACERATIONS. PT ON THE TABLE WAS NOT AFFECTED BECAUSE THEY WERE STILL POSITIONED IN THE LEG STIRRUPS. CUSTOMER REPORTS THE 24 INCH LEG EXTENSION FELL BECAUSE STAFF DID NOT POSITION THE TABLE PAD CORRECTLY, THEREFORE IT WAS LAYING OFF THE EDGE OF THE TABLE, COMPROMISING THE CONNECTION. THE STAFF DID NOT REALIZE THE LATCH WAS NOT FULLY CONNECTED AND NOT LOCKED INTO PLACE.

    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