BEUDAMED
    FDA Adverse Event Other Summary report: N

    CATHERIZATION LABORATORY TABLE

    MDR report key: 15153 · Received May 5, 1994

    Report

    Report Number
    15153
    Event Type
    Other
    Date Received
    May 5, 1994
    Date of Event
    January 4, 1994
    Report Date
    April 29, 1994
    Manufacturer
    SIEMENS CORP.
    Product Code
    KXJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN HAD A PROBLEM WITH OPERATION OF THE EQUIPMENT DURING A PROCEDURE. TECH WAS CALLED TO THE ROOM TO CORRECT THE PROBLEM. TECH REMOVED THE "AMP BOX" FROM THE LOWER SIDE OF THE EQUIPMENT, SET THE BOX ON THE FLOOR NEXT TO THE TABLE, AND WORKED ON THE EQUIPMENT. APPARENTLY, THE PROBLEM WAS TAKEN CARE OF, AND THE TECH LEFT THE BOX ON THE FLOOR IN CASE HE NEEDED TO MAKE MORE ADJUSTMENTS DURING THE PROCEDURE. AFTER THE PROCEDURE WAS COMPLETED, THE TABLE WAS LOWERED TO REMOVE THE PT. THE TABLE WAS NOT ABLE TO BE LOWERED TO THE LOWEST POINT, DUE TO OBSTRUCTION FROM THE CORNER OF THE BOX HOLDING THE TABLE UP. THE TABLE IS CHAIN DRIVEN, THE CHAIN WAS LOOSENED BY DOWNWARD PRESSURE FROM MOTOR. THE AMP BOX MOVED FROM UNDER THE TABLE BY THE PRESSURE, AND THIS MOVE CAUSED A SUDDEN DROP IN TABLE OF APPROX 4 INCHES. TABLE IS EQUIPPED WITH MANY SAFETY DEVICES; ONE OF THE SAFETY FEATURES OF THIS TABLE IS A SENSING SWITCH WHICH IS DESIGNED TO MEASURE AND SENSE THE TENSION OF THE CHAIN; IF THE CHAIN LOOSENS, THE POWER TO THE TABLE DISCONNECTS. THE SENSING SWITCH WAS NOT ADJUSTED CORRECTLY AND WAS NOT SENSITIVE ENOUGH TO SENSE THE LOOSE PART OF THE CHAIN AND IT DID NOT SHUT THE UNIT DOWN. PT HAS NOW NOTIFIED HOSP THAT HE IS EXPERIENCING PAIN IN HIS LEFT LOWER BACK AND LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHERIZATION LABORATORY TABLE CATHERIZATION LABORATORY TABLE KXJ SIEMENS CORP. 9023458

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other