MAGNUS

Description of Event or Problem

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOP - 118016F6 - MAGNUS CARBON FIBRE TABLE TOP, 205CM BOLUS, USA USED WITH PHILIPS C-ARM DEVICE. AS IT WAS STATED, THE TABLE MOVEMENTS STOPPED WORKING AND THE FOLLOWING ALERT WAS DISPLAYED: "PHILIPS TUBE NOT WORKING. USE AT YOUR OWN RISK." ACCORDING TO THE PROVIDED INFORMATION, THE STAFF COULD NO LONGER SLIDE THE TABLE TOP BUT WERE ABLE TO MOVE THE PHILIPS C-ARM TO GET INTO THE SAME POSITION AND USE THE OVERRIDE FUNCTIONS TO MOVE THE COLUMN UP AND DOWN. DUE TO THE ISSUE, THE PATIENT WAS MOVED TO ANOTHER TABLE, WHICH CAUSED A DELAY OF APPROXIMATELY 10 MINUTES IN THE ENDOVASCULAR PROCEDURE. ACCORDING TO INFORMATION PROVIDED FOLLOWING SERVICE VISIT ON SITE, THE LATERAL SHIFT DRIVE AND CONTROL UNIT WERE REPLACED. THE INCIDENT WAS INITIALLY ASSESSED AS REPORTABLE DUE TO A PROCEDURAL DELAY RELATED TO TRANSFER OF THE PATIENT TO ANOTHER OPERATING ROOM DURING PROCEDURE. RECENTLY, THE INCIDENT HAS BEEN REEVALUATED. IT HAS BEEN CONCLUDED THAT THE PROCEDURAL DELAY HAD MINOR CLINICAL RELEVANCE IN THIS SITUATION AND DID NOT LEAD TO ANY HEALTH CONSEQUENCES FOR THE PATIENT. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOP - 118016F6 - MAGNUS CARBON FIBRE TABLE TOP, 205CM BOLUS, USA USED WITH PHILIPS C-ARM DEVICE. AS IT WAS STATED, THE TABLE MOVEMENTS STOPPED WORKING AND THE FOLLOWING ALERT WAS DISPLAYED: "PHILIPS TUBE NOT WORKING. USE AT YOUR OWN RISK." ACCORDING TO THE PROVIDED INFORMATION, THE STAFF COULD NO LONGER SLIDE THE TABLE TOP BUT WERE ABLE TO MOVE THE PHILIPS C-ARM TO GET INTO THE SAME POSITION AND USE THE OVERRIDE FUNCTIONS TO MOVE THE COLUMN UP AND DOWN. DUE TO THE ISSUE, THE PATIENT WAS MOVED TO ANOTHER TABLE, WHICH CAUSED A DELAY OF APPROXIMATELY 10 MINUTES IN THE ENDOVASCULAR PROCEDURE. ACCORDING TO INFORMATION PROVIDED FOLLOWING SERVICE VISIT ON SITE, THE LATERAL SHIFT DRIVE AND CONTROL UNIT WERE REPLACED. THE INCIDENT WAS INITIALLY ASSESSED AS REPORTABLE DUE TO A PROCEDURAL DELAY RELATED TO TRANSFER OF THE PATIENT TO ANOTHER OPERATING ROOM DURING PROCEDURE. RECENTLY, THE INCIDENT HAS BEEN REEVALUATED. IT HAS BEEN CONCLUDED THAT THE PROCEDURAL DELAY HAD MINOR CLINICAL RELEVANCE IN THIS SITUATION AND DID NOT LEAD TO ANY HEALTH CONSEQUENCES FOR THE PATIENT. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE. IT WAS ESTABLISHED THAT THE DEVICE FAILED TO MEET THE MANUFACTURER'S SPECIFICATION. THE DEVICE WAS BEING USED FOR PATIENT TREATMENT WHEN THE MALFUNCTION OCCURRED. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE DEVICE MANUFACTURING OR DEVICES ON THE MARKET, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION. THE CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM, G2 REPORT SOURCE, H6 HEALTH EFFECT ¿ IMPACT CODE FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOP - 118016F6 - MAGNUS CARBON FIBRE TABLE TOP, 205CM BOLUS, USA USED WITH PHILIPS C-ARM DEVICE. AS IT WAS STATED, THE TABLE MOVEMENTS STOPPED WORKING AND THE FOLLOWING ALERT WAS DISPLAYED: "PHILIPS TUBE NOT WORKING. USE AT YOUR OWN RISK." ACCORDING TO THE PROVIDED INFORMATION, THE STAFF COULD NO LONGER SLIDE THE TABLE TOP BUT WERE ABLE TO MOVE THE PHILIPS C-ARM TO GET INTO THE SAME POSITION AND USE THE OVERRIDE FUNCTIONS TO MOVE THE COLUMN UP AND DOWN. DUE TO THE ISSUE, THE PATIENT WAS MOVED TO ANOTHER TABLE, WHICH CAUSED A DELAY OF APPROXIMATELY 10 MINUTES IN THE ENDOVASCULAR PROCEDURE. ACCORDING TO INFORMATION PROVIDED FOLLOWING SERVICE VISIT ON SITE, THE LATERAL SHIFT DRIVE AND CONTROL UNIT WERE REPLACED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY PROCEDURAL DELAY RELATED TO TRANSFER OF THE PATIENT TO ANOTHER OPERATING ROOM DURING PROCEDURE, WAS TO REOCCUR. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOP - 118016F6 - MAGNUS CARBON FIBRE TABLE TOP, 205CM BOLUS, USA USED WITH PHILIPS C-ARM DEVICE. AS IT WAS STATED, THE TABLE MOVEMENTS STOPPED WORKING AND THE FOLLOWING ALERT WAS DISPLAYED: "PHILIPS TUBE NOT WORKING. USE AT YOUR OWN RISK." ACCORDING TO THE PROVIDED INFORMATION, THE STAFF COULD NO LONGER SLIDE THE TABLE TOP BUT WERE ABLE TO MOVE THE PHILIPS C-ARM TO GET INTO THE SAME POSITION AND USE THE OVERRIDE FUNCTIONS TO MOVE THE COLUMN UP AND DOWN. DUE TO THE ISSUE, THE PATIENT WAS MOVED TO ANOTHER TABLE, WHICH CAUSED A DELAY OF APPROXIMATELY 10 MINUTES IN THE ENDOVASCULAR PROCEDURE. ACCORDING TO INFORMATION PROVIDED FOLLOWING SERVICE VISIT ON SITE, THE LATERAL SHIFT DRIVE AND CONTROL UNIT WERE REPLACED. THE INCIDENT WAS INITIALLY ASSESSED AS REPORTABLE DUE TO A PROCEDURAL DELAY RELATED TO TRANSFER OF THE PATIENT TO ANOTHER OPERATING ROOM DURING PROCEDURE. RECENTLY, THE INCIDENT HAS BEEN REEVALUATED. IT HAS BEEN CONCLUDED THAT THE PROCEDURAL DELAY HAD MINOR CLINICAL RELEVANCE IN THIS SITUATION AND DID NOT LEAD TO ANY HEALTH CONSEQUENCES FOR THE PATIENT. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE. PREVIOUS G2 REPORT SOURCE: FOREIGN, USER FACILITY, COMPANY REPRESENTATIVE; CORRECTED G2 REPORT SOURCE: USER FACILITY, COMPANY REPRESENTATIVE. PREVIOUS H6 HEALTH EFFECT ¿ IMPACT CODES: DELAY TO TREATMENT/ THERAPY///4604. CORRECTED H6 HEALTH EFFECT ¿ IMPACT CODES: SURGICAL INTERVENTION/PROLONGED SURGERY//F1908.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. E1 EVENT SITE NAME: (B)(6) MEDICAL CENTER.

Description of Event or Problem

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOP - 118016F6 - MAGNUS CARBON FIBRE TABLE TOP, 205CM BOLUS, USA USED WITH PHILIPS C-ARM DEVICE. AS IT WAS STATED, THE TABLE MOVEMENTS STOPPED WORKING AND THE FOLLOWING ALERT WAS DISPLAYED: "PHILIPS TUBE NOT WORKING. USE AT YOUR OWN RISK." ACCORDING TO THE PROVIDED INFORMATION, THE STAFF COULD NO LONGER SLIDE THE TABLE TOP BUT WERE ABLE TO MOVE THE PHILIPS C-ARM TO GET INTO THE SAME POSITION AND USE THE OVERRIDE FUNCTIONS TO MOVE THE COLUMN UP AND DOWN. DUE TO THE ISSUE, THE PATIENT WAS MOVED TO ANOTHER TABLE, WHICH CAUSED A DELAY OF APPROXIMATELY 10 MINUTES IN THE ENDOVASCULAR PROCEDURE. ACCORDING TO INFORMATION PROVIDED FOLLOWING SERVICE VISIT ON SITE, THE LATERAL SHIFT DRIVE AND CONTROL UNIT WERE REPLACED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY PROCEDURAL DELAY RELATED TO TRANSFER OF THE PATIENT TO ANOTHER OPERATING ROOM DURING PROCEDURE, WAS TO REOCCUR.