BEUDAMED
    FDA Adverse Event Summary report: N

    HAUSTED STRETCHER

    MDR report key: 2191425 · Received August 4, 2011

    Report

    Report Number
    1043572-2011-00035
    Date Received
    August 4, 2011
    Date of Event
    July 7, 2011
    Report Date
    August 4, 2011
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FPO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT USER FACILITY PERSONNEL USED THE OVERRIDE SWITCHES TO ARTICULATE THE TABLE TO COMPLETE THE PROCEDURE. IT WAS LATER IDENTIFIED THAT A STERIS SERVICE TECHNICIAN ARRIVED ON SITE PRIOR TO THE START OF THE PATIENT PROCEDURE; THE PATIENT WAS ON THE TABLE BEING PREPARED FOR THE PROCEDURE WHEN THE HAND CONTROL BECAME NON-RESPONSIVE. THE TECHNICIAN NOTED THAT THE WIRING ON ONE OF THE FLOOR LOCK SWITCHES WAS MAKING AN INTERMITTENT CONNECTION CAUSING THE HAND CONTROL TO NOT RESPOND. THE TECHNICIAN TEMPORARILY REPAIRED THE CONNECTION ENSURING THE TABLE REMAINED LOCKED FOR THE CASE TO CONTINUE WITHOUT DELAY.

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE STRETCHER AND FOUND THE CRANK ASSEMBLY USED TO RAISE THE BACK SECTION HAD EXCESSIVE WEAR CAUSING IT TO BE TIGHT AND DIFFICULT TO USE. THE TECHNICIAN REPLACED THE CRANK ASSEMBLY, TESTED AND PLACED THE STRETCHER BACK INTO SERVICE. THE STRETCHER IS NOT UNDER STERIS SERVICE CONTRACT AND THE USER FACILITY DOES NOT UTILIZE A BIOMEDICAL SERVICE. THE OPERATOR / SERVICE MANUAL STATES (PP. 5-1): "LUBRICATE ALL MOVING AND SLIDING PARTS AND HINGE POINTS EVERY 3 MONTHS."

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AN EMPLOYEE WAS TURNING A HANDLE TO RAISE THE BACK SECTION OF THE STRETCHER AND FELT PAIN. THE EMPLOYEE SOUGHT MEDICAL ATTENTION AND WAS DIAGNOSED WITH A LUMBAR STRAIN AND RADICULOPATHY. THE USER FACILITY REPORTS THE EMPLOYEE HAS RETURNED TO NORMAL WORK DUTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAUSTED STRETCHER STRETCHER FPO STERIS CORPORATION - MONTGOMERY 578

    Patients

    Seq Age Sex Outcome Treatment
    1 Other