PST 500

Additional Manufacturer Narrative

INSPECTION OF THE DEVICE IS PENDING AND RESULTS WILL BE PROVIDED BY A FINAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT A PST500 SURGICAL TABLE WAS UNLOCKING DURING PROCEDURE, CAUSING THE TABLE TO REST ON IT WHEELS. IT WAS NOTED THAT ¿THIS RESULTED IN INCIDENTS WHERE STAFF HAVE HAD THEIR FEET CAUGHT¿. THERE IS NO INDICATION THAT THE REPORTED INCIDENTS WERE SERIOUS IN NATURE, AND THERE WAS NO REPORT OF REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE.

Description of Event or Problem

IT WAS REPORTED THAT PST500 OR TABLE WAS SINKING DURING PROCEDURE, CAUSING THE STRUCTURES TO REST ON THEIR WHEELS. IT WAS NOTED THAT ¿THIS RESULTED IN INCIDENTS WHERE STAFF HAVE HAD THEIR FEET CAUGHT¿. DURING FOLLOW-UP, THE CUSTOMER CONFIRMED THAT THE EVENT DID NOT RESULT IN INJURY, AND THERE WAS NO REPORT OF MEDICAL INTERVENTION REQUIRED.

Additional Manufacturer Narrative

THE DEVICE MALFUNCTION A REVIEW OF THE DEVICE'S RISK FILES DETERMINED THAT THE LIKELIHOOD OF A SIMILAR EVENT (TABLE MOVES DURING A SURGICAL INTERVENTION BECAUSE THE BRAKE¿S JACKING MECHANISM FAILS) LEADING TO A CRITICAL INJURY (MUSCULAR/SKELETAL INJURY) IS IMPROBABLE, THEREFORE, IT CAN BE REASONABLE CONCLUDED THAT IF A SIMILAR EVENT WERE TO RECUR IT WOULD BE UNLIKELY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. AFTER THE EVENT OCCURRED THE CUSTOMER CONTINUED TO USE THE DEVICE INVOLVED WITHOUT ANY FURTHER ISSUE. A SERVICE TECHNICIAN FROM A BAXTER AUTHORIZED DISTRIBUTOR IN (B)(6) EXCHANGED THE HYDRAULIC UNIT AND THE FLOOR STAMPS IN (B)(6) 2025. THE EXCHANGED PARTS WERE SENT TO THE BAXTER MANUFACTURING PLANT FOR FURTHER ANALYSIS. IN A FIRST INSTANCE THE PARTS WERE INSTALLED IN A DIFFERENT PST 500 SURGICAL TABLE AND TESTS WERE PERFORMED. THE REPORTED FAILURE MODE OF UNINTENDED UN-LOCKING (THE ALLEGED ¿SINKING¿ FROM THE ORIGINAL CUSTOMER REPORT) COULD NOT BE REPRODUCED. THE HYDRAULIC UNIT AND THE FLOOR STAMPS WERE WORKING AS INTENDED. IDENTIFYING THE ROOT CAUSE OF A NON-REPRODUCIBLE FAILURE REQUIRES THOROUGH AND SYSTEMATIC ANALYSIS, THEREFORE BAXTER WAS NOT ABLE TO ESTABLISH A ROOT CAUSE AT THIS TIME AND WILL CONTINUE WITH THE ROOT CAUSE ANALYSIS AND FURTHER TESTING OF THE PARTS INVOLVED IN THE EVENT. THE ALLEGED FAILURE MODE WILL BE MONITORED FURTHER VIA POST-MARKET SURVEILLANCE ACTIVITIES. A FOLLOW-UP WITH THE CUSTOMER CONFIRMED THAT NO INJURY OCCURRED BASED ON THE REPORTED EVENT.