PST500

Additional Manufacturer Narrative

INVESTIGATION IS ONGOING. ALL ADDITIONAL AND RELEVANT INFORMATION THAT IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION WILL BE SUBMITTED IN A FINAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THE PST 500 U HAD AN ISSUE; AFTER LOCKING THE WHEELS THEY RELEASE PRESSURE AND TABLE MOVES. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

Description of Event or Problem

IT WAS REPORTED THAT THE PST 500 U HAD AN ISSUE, AFTER LOCKING THE WHEELS THEY RELEASE PRESSURE AND TABLE MOVES. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

THE MEDICAL DEVICE PST 500 IS A MOBILE AND CONFIGURABLE OPERATING TABLE, WHICH IS INTENDED TO BE USED IN COMBINATION WITH SPECIFIC TABLETOP SECTIONS, PADS AND ACCESSORIES FOR PATIENT POSITIONING ON THE OPERATING TABLE DURING SURGERY, FROM THE INDUCTION OF ANAESTHESIA THROUGH THE ACTUAL SURGERY TO RECOVERY FROM ANAESTHESIA. DURING ON-SITE INVESTIGATION BY A BAXTER FIELD SERVICE TECHNICIAN REPLACED THE HYDRAULIC UNIT AND FLOOR LOCKS, WHICH ARE RESPONSIBLE FOR THE TABLES BRAKE. A FURTHER INVESTIGATION AT THE MANUFACTURING PLANT BAXTER SAALFELD COULD NOT DUPLICATE ANY ISSUE WITH THESE PARTS. THE ALLEGED FAILURE MODE WILL BE MONITORED FURTHER VIA POST-MARKET SURVEILLANCE ACTIVITIES AND TESTING WILL CONTINUE TO IDENTIFY A ROOT CAUSE. BASED ON THIS, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF WHEELS RELEASING PRESSURE WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS EVENT.