TRANSPORTER

Description of Event or Problem

THE FOLLOWING WAS REPORTED TO US. AFTER A SURGERY THE USER TRIED TO TRANSFER THE TABLE TOP 115010DE WITH THE PATIENT TO THE TRANSPORTER 114061C0. THE TABLE TOP WAS IN THE BEACH CHAIR POSITION AND THE PATIENT WAS VENTILATED. A PART OF THE TRANSPORTER CARRIER FRAME BROKE AND THE TABLE TOP TILTED. THE PATIENT STARTED TO SLIDE. THE OR TEAM TRIED TO SUPPORT THE TABLE AND HOLD THE PATIENT. TWO PEOPLE GOT STRAINS OF THEIR BACK DUE TO THIS. WE WERE INITIALLY INFORMED THAT THE PATIENT WAS ALSO INJURED. WE HAVE SINCE BEEN INFORMED THAT THE PATIENT WAS NOT INJURED.

Additional Manufacturer Narrative

THE AFFECTED TRANSPORTER WAS RETURNED TO THE FACTORY FOR FURTHER INVESTIGATION. DURING THE INVESTIGATION, IT WAS FOUND THAT ONE OF THE TWO SCREWS CONNECTING THE UPPER PART OF THE TRANSPORTER TO TWO SUPPORTS HAD COME LOOSE. BOTH THE SUPPORTS AND THE UPPER PART ARE PART OF THE SUPPORTING FRAME. THE STORAGE AREA IS CONNECTED TO THE UPPER PART OF THE TRANSPORTER VIA TWO INTERFACES. SINCE THIS UPPER PART WAS NO LONGER CONNECTED TO BOTH SUPPORTS, THE MALFUNCTION DESCRIBED (DAMAGE TO THE SUPPORT FRAME) OCCURRED AND THE TABLE TOP TILTED. THE PRODUCT IN QUESTION HAD BEEN IN CLINICAL USE FOR OVER 20 YEARS, SO WE ASSUME THAT THE SCREW CAME LOOSE OVER TIME DUE TO WEAR AND TEAR. THE LAST MAINTENANCE WAS PERFORMED IN FEBRUARY 2020 BY GETINGE ¿ MAQUET SERVICE TECHNICIAN AND NO LOOSENED SCREW WAS DETECTED. THE COMPLETE EVENT SITE NAME IS (B)(6). THE COMPLETE PHONE NUMBER OF THE INITIAL REPORTER IS: (B)(6). THE CORRECTION OF A1 PATIENT IDENTIFIER AND B5 DESCRIBE EVENT OR PROBLEM FIELDS DEEMS REQUIRED. THIS IS BASED ON INTERNAL EVALUATION AND THE ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED. PREVIOUS A1 PATIENT IDENTIFIER (B)(6). CORRECTED A1 PATIENT IDENTIFIER (B)(6). PREVIOUS B5 DESCRIBE EVENT OR PROBLEM THE FOLLOWING WAS REPORTED TO US. AFTER A SURGERY THE USER TRIED TO TRANSFER THE TABLE TOP 115010DE WITH THE PATIENT TO THE TRANSPORTER 114061C0. THE TABLE TOP WAS IN THE BEACH CHAIR POSITION AND THE PATIENT WAS VENTILATED. A PART OF THE TRANSPORTERS CARRIER FRAME BROKE AND THE TABLE TOP TILTED. THE PATIENT STARTED TO SLIDE. THE OR TEAM TRIED TO SUPPORT THE TABLE AND HOLD THE PATIENT. TWO PERSONS GOT STRAINS IN THEIR BACK DUE TO THIS. THE PATIENT IS SAID TO BE INJURED, TOO. WE HAVE REQUESTED FURTHER INFORMATION CONCERNING THE KIND OF INJURY, BUT NOT RECEIVED AN ANSWER YET. MANUFACTURER REFERENCE# (B)(4). CORRECTED B5 DESCRIBE EVENT OR PROBLEM. THE FOLLOWING WAS REPORTED TO US. AFTER A SURGERY THE USER TRIED TO TRANSFER THE TABLE TOP 115010DE WITH THE PATIENT TO THE TRANSPORTER 114061C0. THE TABLE TOP WAS IN THE BEACH CHAIR POSITION AND THE PATIENT WAS VENTILATED. A PART OF THE TRANSPORTER CARRIER FRAME BROKE AND THE TABLE TOP TILTED. THE PATIENT STARTED TO SLIDE. THE OR TEAM TRIED TO SUPPORT THE TABLE AND HOLD THE PATIENT. TWO PEOPLE GOT STRAINS OF THEIR BACK DUE TO THIS. WE WERE INITIALLY INFORMED THAT THE PATIENT WAS ALSO INJURED. WE HAVE SINCE BEEN INFORMED THAT THE PATIENT WAS NOT INJURED.

Additional Manufacturer Narrative

AT TIME OF THIS REPORT THE INVESTIGATION IS STILL ONGOING. WHEN THE INVESTIGATION IS COMPLETE THE REPORT WILL BE UPDATED AND A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED. (B)(6).

Description of Event or Problem

THE FOLLOWING WAS REPORTED TO US. AFTER A SURGERY THE USER TRIED TO TRANSFER THE TABLE TOP 115010DE WITH THE PATIENT TO THE TRANSPORTER 114061C0. THE TABLE TOP WAS IN THE BEACH CHAIR POSITION AND THE PATIENT WAS VENTILATED. A PART OF THE TRANSPORTERS CARRIER FRAME BROKE AND THE TABLE TOP TILTED. THE PATIENT STARTED TO SLIDE. THE OPERATING ROOM TEAM TRIED TO SUPPORT THE TABLE AND HOLD THE PATIENT. TWO PERSONS GOT STRAINS IN THEIR BACK DUE TO THIS. THE PATIENT IS SAID TO BE INJURED, TOO. WE HAVE REQUESTED FURTHER INFORMATION CONCERNING THE KIND OF INJURY, BUT NOT RECEIVED AN ANSWER YET. MANUFACTURER REFERENCE# (B)(4).