MAGNUS OPERATING TABLE SYSTEM
Report
- Report Number
- 3013876692-2023-00049
- Event Type
- Death
- Date Received
- October 17, 2023
- Date of Event
- August 10, 2023
- Report Date
- July 8, 2024
- Manufacturer
- MAQUET GMBH
- Product Code
- FQO
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. E1B EVENT SITE NAME: (B)(6) HOSPITAL. PHILIPS REPORT NUMBER: 3003768277-2023-04672. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.
ON 14TH SEPTEMBER 2023, GETINGE WAS ORALLY INFORMED BY PHILIPS ABOUT AN INCIDENT WITH AZURION (MANUFACTURED BY PHILIPS) USED WITH ONE OF OUR COLUMNS - 118001B1 - HYBRID OR TABLE COLUMN. AS IT WAS STATED, THE ISSUE OCCURRED DURING AN INTEGRATION BETWEEN FLEXARM AND MAGNUS WHILE THE PATIENT WAS ON THE TABLE. THE INITIALLY PROVIDED DETAILS FROM PHILIPS SUGGEST THAT THE ISSUE IS RELATED TO THE PHILIPS DEVICE. FOLLOWING GETINGE'S REQUEST, ON 16TH OCTOBER 2023, FURTHER INFORMATION REGARDING THE INCIDENT HAS BEEN RECEIVED. IT WAS REPORTED THAT THE PHILIPS DEVICE AZURION 7M20 SYSTEM PROMPTED AN ERROR MESSAGE (TABLE COLLISION DETECTED) THAT IMPACTED COMMUNICATION BETWEEN THE GETINGE DEVICE 118001B1 - HYBRID OR TABLE COLUMN AND THE AZURION. THE SYSTEM WAS IN CLINICAL USE WITH THE PATIENT, WHEN THE ISSUE OCCURRED THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO COMPLETE THE CARDIAC PROCEDURE. IT IS ALLEGED THAT THE PATIENT DIED AS A RESULT OF THE DELAY IN TREATMENT. WE DECIDED TO REPORT THE INCIDENT DUE TO THE DEATH OF THE PATIENT AS THE HYBRID OR TABLE COLUMN INVOLVEMENT IN THIS ISSUE CANNOT BE EXCLUDED. FURTHER INFORMATION REGARDING THE PATIENT'S DEATH WAS NOT RECEIVED AS THE PATIENT DID NOT PASS AWAY AT THE CUSTOMER SITE WHERE THE INCIDENT HAPPENED AND THE HOSPITAL CANNOT REPORT ON THE CAUSE OF THE ALLEGED DEATH. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR THE PATIENT¿S TREATMENT, AND THUS WAS ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS THE COMMUNICATION ISSUES BETWEEN MAGNUS TABLE COLUMN AND PHILIPS SYSTEM WERE CAUSED BY THE MALFUNCTION OF THE PHILIPS DEVICE, IT WAS CONSIDERED THAT THE GETINGE DEVICE DID NOT FAIL TO MEET ITS SPECIFICATIONS. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT IN ONE COMPLAINT THE PATIENT¿S DEATH WAS REPORTED WHEN THIS PARTICULAR MALFUNCTION OCCURRED. COMPARING THE NUMBER OF DEVICES INVOLVED IN THE ADVERSE EVENT TO THE NUMBER 118001B1 - HYBRID OR TABLE COLUMN ON THE MARKET WE CAN CONCLUDE THE FAILURE RATIO IS 0,76% FOR THE ISSUE INVESTIGATED HEREIN. THE DESCRIBED COMMUNICATION ISSUES WERE INVESTIGATED WITHIN CAPA 2023-011 AND FURTHER INVESTIGATION AT PHILIPS, APPROPRIATE ACTIONS HAVE BEEN DECIDED. DURING THE CAPA PROCESS, IT WAS ESTABLISHED THAT THREE DIFFERENT COMMUNICATION ISSUES CAN OCCUR BETWEEN THE PHILIPS AND MAGNUS SYSTEM DUE TO THE PHILIPS FLEX ARM-SYSTEM. THESE COMMUNICATION ISSUES OFTEN OCCUR IN COMBINATION AND HAVE BEEN PRESENT SINCE CHANGES FROM PHILIPS. DUE TO THIS, THE RISK IS PRESENT THAT ANY MOVEMENT OF OUR TABLE IS IMPOSSIBLE. THE FLEX ARM MOVEMENT IS ALSO IMPOSSIBLE WHEN THE ISSUES OCCUR. FURTHER, IT WAS ESTABLISHED THAT THREE COMMUNICATION ISSUES (COLLISION DETECT/ TRIGGER SETTIME/ FRAME OVERLOADING) WERE CAUSED DUE TO THE PHILIPS SYSTEM AND THE MAGNUS OPERATING TABLE DID NOT CAUSE THE PROBLEM. AFTER INVESTIGATION, ALL THREE ISSUES WERE RELATED TO THE VIOLATION OR THE MISUSE OF THE INTERFACE SPECIFICATION BY THE INTERFACE PARTNER. THEREFORE, THE ROOT CAUSE FOR THE ISSUE IS LOCALIZED AT THE INTERFACE PARTNER AND THEIR SYSTEM. IN SUMMARY AND AS A RESULT OF THE ROOT CAUSE EVALUATION PERFORMED BY THE MANUFACTURERS OF THE AFFECTED DEVICES, IT CAN BE CONCLUDED THAT THE ROOT CAUSE OF THE REPORTED ISSUE, NAMELY THE PATIENT DEATH AS A RESULT OF THE DELAY IN TREATMENT, IS RELATED TO THE MALFUNCTION OF THE PHILIPS SYSTEM AND THE MALFUNCTION OF THE GETINGE DEVICE COULD NOT BE CONFIRMED. THE DESCRIBED COMMUNICATION ISSUES WERE INVESTIGATED WITHIN CAPA 2023-011 AND FURTHER INVESTIGATION AT PHILIPS, APPROPRIATE ACTIONS HAVE BEEN DECIDED. THE CORRECTION OF B1 ADVERSE EVENT / PRODUCT PROBLEM, B5 DESCRIBE EVENT OR PROBLEM, D1 BRAND NAME, D4 CATALOG #, H3C IF OTHER PROVIDE CODE - EXPLAIN, H4 DEVICE MANUFACTURE DATE AND H6 MEDICAL DEVICE ¿ PROBLEM CODE FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B1 ADVERSE EVENT / PRODUCT PROBLEM: ADVERSE EVENT & PRODUCT PROBLEM CORRECTED B1 ADVERSE EVENT / PRODUCT PROBLEM: ADVERSE EVENT. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 14TH SEPTEMBER 2023 GETINGE WAS ORALLY INFORMED BY PHILIPS ABOUT AN INCIDENT WITH AZURION (MANUFACTURED BY PHILIPS) USED WITH ONE OF OUR COLUMNS - 118001B1 - HYBRID OR TABLE COLUMN. AS IT WAS STATED, THE ISSUE OCCURRED DURING AN INTEGRATION BETWEEN FLEXARM AND MAGNUS WHILE THE PATIENT WAS ON THE TABLE. THE INITIALLY PROVIDED DETAILS FROM PHILIPS SUGGESTS THAT THE ISSUE IS RELATED TO THE PHILIPS DEVICE. FOLLOWING GETINGE REQUEST, ON 16TH OCTOBER 2023, FURTHER INFORMATION REGARDING THE INCIDENT HAS BEEN RECEIVED. IT WAS REPORTED THAT PHILIPS DEVICE AZURION 7M20 SYSTEM PROMPTED AN ERROR MESSAGE (TABLE COLLISION DETECTED) THAT IMPACTED COMMUNICATION BETWEEN THE GETINGE DEVICE 118001B1 - HYBRID OR TABLE COLUMN AND THE AZURION. THE SYSTEM WAS IN CLINICAL USE WITH THE PATIENT, WHEN THE ISSUE OCCURRED THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO COMPLETE THE CARDIAC PROCEDURE. IT IS ALLEGED THAT THE PATIENT DIED AS A RESULT OF THE DELAY IN TREATMENT. WE DECIDED TO REPORT THE INCIDENT DUE TO DEATH OF THE PATIENT AS THE HYBRID OR TABLE COLUMN INVOLVEMENT IN THIS ISSUE CANNOT BE EXCLUDED. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON 14TH SEPTEMBER 2023, GETINGE WAS ORALLY INFORMED BY PHILIPS ABOUT AN INCIDENT WITH AZURION (MANUFACTURED BY PHILIPS) USED WITH ONE OF OUR COLUMNS - 118001B1 - HYBRID OR TABLE COLUMN. AS IT WAS STATED, THE ISSUE OCCURRED DURING AN INTEGRATION BETWEEN FLEXARM AND MAGNUS WHILE THE PATIENT WAS ON THE TABLE. THE INITIALLY PROVIDED DETAILS FROM PHILIPS SUGGEST THAT THE ISSUE IS RELATED TO THE PHILIPS DEVICE. FOLLOWING GETINGE'S REQUEST, ON 16TH OCTOBER 2023, FURTHER INFORMATION REGARDING THE INCIDENT HAS BEEN RECEIVED. IT WAS REPORTED THAT THE PHILIPS DEVICE AZURION 7M20 SYSTEM PROMPTED AN ERROR MESSAGE (TABLE COLLISION DETECTED) THAT IMPACTED COMMUNICATION BETWEEN THE GETINGE DEVICE 118001B1 - HYBRID OR TABLE COLUMN AND THE AZURION. THE SYSTEM WAS IN CLINICAL USE WITH THE PATIENT, WHEN THE ISSUE OCCURRED THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO COMPLETE THE CARDIAC PROCEDURE. IT IS ALLEGED THAT THE PATIENT DIED AS A RESULT OF THE DELAY IN TREATMENT. WE DECIDED TO REPORT THE INCIDENT DUE TO THE DEATH OF THE PATIENT AS THE HYBRID OR TABLE COLUMN INVOLVEMENT IN THIS ISSUE CANNOT BE EXCLUDED. FURTHER INFORMATION REGARDING THE PATIENT'S DEATH WAS NOT RECEIVED AS THE PATIENT DID NOT PASS AWAY AT THE CUSTOMER SITE WHERE THE INCIDENT HAPPENED AND THE HOSPITAL CANNOT REPORT ON THE CAUSE OF THE ALLEGED DEATH. PREVIOUS D1 BRAND NAME: HYBRID OR TABLE COLUMN, SURFACE-MOUNTED CORRECTED D1 BRAND NAME: MAGNUS OPERATING TABLE SYSTEM. PREVIOUS D4 CATALOG #: 118001B1. CORRECTED D4 CATALOG #: N/A. PREVIOUS D9 DEVICE AVAILABLE FOR EVALUATION: YES. CORRECTED D9 DEVICE AVAILABLE FOR EVALUATION: NO. PREVIOUS H3C IF OTHER PROVIDE CODE - EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C IF OTHER PROVIDE CODE - EXPLAIN: THIRD PARTY SERVICE INSPECTION. PREVIOUS H4 DEVICE MANUFACTURE DATE: 10/01/2021. CORRECTED H4 DEVICE MANUFACTURE DATE: 09/07/2021. PREVIOUS H6 MEDICAL DEVICE ¿ PROBLEM CODE: COMMUNICATION OR TRANSMISSION PROBLEM///2896. CORRECTED H6 MEDICAL DEVICE ¿ PROBLEM CODE: ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM///2993 H3 OTHER TEXT : THIRD PARTY SERVICE INSPECTION.
ON (B)(6) 2023 GETINGE WAS ORALLY INFORMED BY PHILIPS ABOUT AN INCIDENT WITH AZURION (MANUFACTURED BY PHILIPS) USED WITH ONE OF OUR COLUMNS - 118001B1 - HYBRID OR TABLE COLUMN. AS IT WAS STATED, THE ISSUE OCCURRED DURING AN INTEGRATION BETWEEN FLEXARM AND MAGNUS WHILE THE PATIENT WAS ON THE TABLE. THE INITIALLY PROVIDED DETAILS FROM PHILIPS SUGGESTS THAT THE ISSUE IS RELATED TO THE PHILIPS DEVICE. FOLLOWING GETINGE REQUEST, ON 16TH OCTOBER 2023, FURTHER INFORMATION REGARDING THE INCIDENT HAS BEEN RECEIVED. IT WAS REPORTED THAT PHILIPS DEVICE AZURION 7M20 SYSTEM PROMPTED AN ERROR MESSAGE (TABLE COLLISION DETECTED) THAT IMPACTED COMMUNICATION BETWEEN THE GETINGE DEVICE 118001B1 - HYBRID OR TABLE COLUMN AND THE AZURION. THE SYSTEM WAS IN CLINICAL USE WITH THE PATIENT, WHEN THE ISSUE OCCURRED THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO COMPLETE THE CARDIAC PROCEDURE. IT IS ALLEGED THAT THE PATIENT DIED AS A RESULT OF THE DELAY IN TREATMENT. WE DECIDED TO REPORT THE INCIDENT DUE TO DEATH OF THE PATIENT AS THE HYBRID OR TABLE COLUMN INVOLVEMENT IN THIS ISSUE CANNOT BE EXCLUDED.
ON 14TH SEPTEMBER 2023, GETINGE WAS ORALLY INFORMED BY PHILIPS ABOUT AN INCIDENT WITH AZURION (MANUFACTURED BY PHILIPS) USED WITH ONE OF OUR COLUMNS - 118001B1 - HYBRID OR TABLE COLUMN. AS IT WAS STATED, THE ISSUE OCCURRED DURING AN INTEGRATION BETWEEN FLEXARM AND MAGNUS WHILE THE PATIENT WAS ON THE TABLE. THE INITIALLY PROVIDED DETAILS FROM PHILIPS SUGGEST THAT THE ISSUE IS RELATED TO THE PHILIPS DEVICE. FOLLOWING GETINGE'S REQUEST, ON 16TH OCTOBER 2023, FURTHER INFORMATION REGARDING THE INCIDENT HAS BEEN RECEIVED. IT WAS REPORTED THAT THE PHILIPS DEVICE AZURION 7M20 SYSTEM PROMPTED AN ERROR MESSAGE (TABLE COLLISION DETECTED) THAT IMPACTED COMMUNICATION BETWEEN THE GETINGE DEVICE 118001B1 - HYBRID OR TABLE COLUMN AND THE AZURION. THE SYSTEM WAS IN CLINICAL USE WITH THE PATIENT, WHEN THE ISSUE OCCURRED THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO COMPLETE THE CARDIAC PROCEDURE. IT IS ALLEGED THAT THE PATIENT DIED AS A RESULT OF THE DELAY IN TREATMENT. WE DECIDED TO REPORT THE INCIDENT DUE TO THE DEATH OF THE PATIENT AS THE HYBRID OR TABLE COLUMN INVOLVEMENT IN THIS ISSUE CANNOT BE EXCLUDED. FURTHER INFORMATION REGARDING THE PATIENT'S DEATH WAS NOT RECEIVED AS THE PATIENT DID NOT PASS AWAY AT THE CUSTOMER SITE WHERE THE INCIDENT HAPPENED AND THE HOSPITAL CANNOT REPORT ON THE CAUSE OF THE ALLEGED DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1750032 | MAGNUS OPERATING TABLE SYSTEM | TABLE, OPERATING-ROOM, AC-POWERED | FQO | MAQUET GMBH | 118001B1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose | Death |