BEUDAMED
    FDA Adverse Event Summary report: N

    4085 SURGICAL TABLE

    MDR report key: 2921025 · Received January 17, 2013

    Report

    Report Number
    1043572-2013-00007
    Date Received
    January 17, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 17, 2013
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE TECHNOLOGY PRODUCT SPECIALIST OFFERED AN IN-SERVICE TRAINING TO THE HOSPITAL STAFF ON PROPER USE AND OPERATION OF THE TABLE WHICH WAS DECLINED. A LETTER SENT TO THE USER FACILITY, FROM DEVICE TECHNOLOGIES, STATES THAT STRENUOUS TABLE INSPECTION WAS PERFORMED INCLUDING TOTAL INSPECTION OF THE ELECTRO-HYDRAULICS AND PERFORMING DIFFERENT COUNTER BALANCE WEIGHT TESTING IN EVERY ARTICULATION THE TABLE HAS TO OFFER. THE TECHNICIAN FURTHER TESTED THE TABLE BY PLAYING HIS TOTAL BODY WEIGHT ON THE LEG SECTION AND HEAD SECTIONS OF THE TABLE TOP WITH THE TABLE HOLDING POSITION. THE TECHNICIAN WAS NOT ABLE TO REPLICATE THE REPORTED EVENT. HOWEVER, AT THE INSISTENCE OF THE CUSTOMER, DTA REPLACED THE MAIN HYDRAULIC "VALVE BLOCK". ALL TABLE FUNCTIONS HAVE BEEN TESTED AND THE TABLE HAS BEEN DEEMED OPERATIONAL.

    Additional Manufacturer Narrative · 1

    A DEVICE TECHNOLOGIES SERVICE TECHNICIAN INSPECTED THE UNIT AND WAS UNABLE TO DUPLICATE THE REPORTED EVENT. THE TECHNICIAN CHECKED THE HYDRAULIC SYSTEM FOR DAMAGE AND LEAKS, THE ELECTRICAL SYSTEM FOR DAMAGE AND LOOSE CONNECTIONS AND INSPECTED ALL TABLE FUNCTIONS. ALL TABLE FUNCTIONS WERE FOUND TO BE OPERATING TO SPECIFICATION. NO REPAIRS TO THE UNIT WERE MADE. IN ORDER FOR THE TABLE TO HAVE MOVED AS DESCRIBED BY THE CUSTOMER, THERE WOULD HAVE TO HAVE BEEN A FAILURE OF THE HYDRAULIC SYSTEM, WHICH WOULD RESULT IN HYDRAULIC FLUID LOSS AND LOSS OF HYDRAULIC PRESSURE FROM THE TABLE. IF THIS HAD HAPPENED, THE TECHNICIAN OR A STAFF MEMBER WOULD HAVE DETECTED HYDRAULIC FLUID ON THE FLOOR. THERE WAS NO EVIDENCE OF A HYDRAULIC FLUID LEAK DURING THE TECHNICIAN'S INSPECTION NOR WAS IT REPORTED BY THE CUSTOMER. IT APPEARS, BASED ON THE CUSTOMER'S DESCRIPTION OF THE EVENT THAT THE TABLE WAS COMMANDED TO ARTICULATE. STERIS WILL OFFER IN-SERVICE ON THE PROPER USE AND OPERATION OF THE TABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A GYNECOLOGY CASE HAD BEEN COMPLETED WITH A PATIENT STILL IN LITHOTOMY POSITION WHEN THE TABLE SLID TO THE FOOT SECTION OF THE BED. THE FACILITY ALLEGED THE PATIENT'S FEET WENT DOWN, AND HEAD CAME UP "VERY QUICKLY". THE PATIENT DID NOT SLIP OFF OF THE TABLE. NO INJURIES WERE REPORTED TO THE PATIENT OR HOSPITAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26398 4085 SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other