MAGNUS operating table system 118001B2Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04046768088351), received between Mar 16, 2023 and Jun 18, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Feb 11, 2021Open, Classified

   There is a potential for hydraulic leakage at the inclination function to occur resulting in an unintended Trendelenburg or anti-Trendelenburg movement of the table top depending on patient positioning which may lead to the patient having to be transferred to another OR table causing a delay in the procedure.

   Z-1296-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025Positioning Failure; Failure to Sense; Positioning Failure; Failure to Sense

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 118001B2 ¿ HYBRID OR TABLE COLUMN, SURFACE-MOUNTED USED WITH 118012A0 - MULTIMODALITY TRANSFER TABLE TOP EU. AS IT WAS STATED, AFTER APPROXIMATELY ONE HOUR OF ONGOING NEUROSURGICAL SURGERY, THE TABLE REPORTED ERROR 104 AND 110 ON THE IR TRANSMITTER WHEN ATTEMPTING THE TRENDELENBURG POSITION, THE OPERATING TABLE COULD ONLY BE MOVED IN THE ANTITRENDELENBURG POSITION. THE REQUIRED POSITION COULD NOT BE REACHED VIA REMOTE HAND CONTROL, AS WELL AS THE OVERRIDE PANEL AND OTHER AVAILABLE CONTROLLERS. THE CONDITION LASTED FOR SEVERAL TENS OF MINUTES, THEN THE TABLE STARTED WORKING AGAIN FOR NO APPARENT REASON. THE SURGERY WAS COMPLETED. THE GETINGE TECHNICIAN WAS UNABLE TO RE-SIMULATE THE FAULT DURING THE TEST. AFTER THE EVALUATION OF THE DOWNLOADED LOG FILES, THE ERRORS RELATED TO THE SENSOR AND COLUMN HEAD WERE FOUND. THE POSITION SENSORS IN THE OPERATING COLUMN AND TABLE TOP WERE RECALIBRATED, AND THE DEVICE WAS RESTORED TO FULL WORKING ORDER AND RETURNED TO SERVICE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE OPERATING TABLE NOT RES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22267467 ↗
• MalfunctionFeb 22, 2024Positioning Failure; Intermittent Communication Failure; Positioning Failure; Intermittent Communication Failure

  ON 7TH FEBRUARY 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 118001B2 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED. AS IT WAS STATED, AN "INTERMITTENT" ISSUE WITH CONNECTION BETWEEN MAGNUS OPERATING TABLE AND C-ARM (MANUFACTURED BY SIEMENS) CAUSING ALL MOVEMENT TO BECOME DISABLED HAS BEEN OCCURING DURING ELECTIVE COMPLEX CARDIAC PROCEDURES OVER THE LAST 2-3 MONTHS. ACCORDING TO THE PROVIDED INFORMATION, THE FAULT WAS NEVER REPLICATED DURING DAILY CHECKS. THERE WAS NO HARM TO PATIENTS, HOWEVER, THE ISSUE CAUSED DELAYS DURING THE PROCEDURES AS THE TABLE REQUIRES REBOOT AND ACTIVATION OF EMERGENCY STOP BUTTONS IN ORDER FOR IT TO RECONNECT AND ALLOW MOVEMENT. THERE IS AN INDICATION THAT THE PROBLEM MAY HAVE OCCURRED MORE THAN ONCE, HOWEVER, TO DATE THE NUMBER OF INCIDENTS COULD NOT BE CONFIRMED. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18756338 ↗
• MalfunctionJan 29, 2024Communication or Transmission Problem; Device Sensing Problem; Communication or Transmission Problem; Device Sensing Problem

  ON 17TH JANUARY 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS: 118001B2 HYBRID OR TABLE COLUMN, SURFACE MOUNTED. AS IT WAS STATED, AN ISSUE WITH THE VERTICAL TILT SENSOR OCCURRED DURING SURGERY ON THE ANESTHETIZED PATIENT RESULTING IN BROKEN INTERLOCKING OF HYBRID OR TABLE COLUMN WITH SIEMENS ANGIOGRAPHY EQUIPMENT. IT WAS RESOLVED BY RESTART OF THE DEVICE WHICH CONSEQUENTLY LED TO A DELAY. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595421 ↗
• MalfunctionJan 5, 2024Computer Software Problem; Failure to Interrogate; Failure to Sense; Intermittent Communication Failure; Computer Software Problem; Failure to Interrogate; Failure to Sense; Intermittent Communication Failure

  ON 21ST DECEMBER 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 118001B2 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED. AS IT WAS STATED, THE OPERATING TABLE LOST CONNECTION WITH SIEMENS ANGIOGRAPHY DEVICE DURING TAVI SURGERY LEADING TO A 1-2 MINUTES DELAY IN A PROCEDURE. WHEN THE INTERLOCKING WAS BROKEN, A SOUND WAS HEARD INTERMITTENTLY ON THE ANGIOGRAPHY SIDE. THE TABLE COULD NOT BE OPERATED WHEN THE POSITION INFORMATION WAS LOST. IT WAS STATED THAT THE RECOVERY IS DONE BY RESTARTING OF ANGIOGRAPHY DEVICE. THE ZERO POSITION WAS ADJUSTED AND THE FOLLOWING PARTS WERE REPLACED AND CALIBRATED DURING SERVICE VISIT ON SITE: HYBRID-OR INTERFACE, COLUMN CONTROLLER UNIT AND TREND POTENTIOMETER. ACCORDING TO PROVIDED INFORMATION, THE PATIENT WAS ANESTHETIZED DURING THE INCIDENT. THE INCIDENT WAS INITIALLY ASSESSED AS REPORTABLE DUE TO A DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME. RECENTLY, THE INCIDENT HAS BEEN REEVALUATED AS ACCORDING TO THE MEDICAL EXPERT'S ASSESSMENT, THE PROCEDURAL DELAY DID NOT HAVE ANY MAJOR CLINICAL RELEVANCE IN THIS SITUATION. THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18452044 ↗
• MalfunctionDec 21, 2023Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  ON 8TH DECEMBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 118001B2 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED. AS IT WAS STATED, COMMUNICATION WITH IMAGINING DEVICE WAS INTERRUPTED AND THE OPERATING TABLE STOPPED MOVING DURING SURGERY ON ANESTHETIZED PATIENT. THE ISSUE LED TO A DELAY OF APPROXIMATELY 10 MINUTES DUE TO RESTART OF THE ANGIOGRAPHY DEVICE. THE STAFF WAS ABLE TO COMPLETE THE PROCEDURE. FOLLOWING THE SERVICE VISIT ON SITE, THE HEIGHT AND TREND SENSORS WERE FOUND TO BE DEFECTIVE. THE INCIDENT WAS INITIALLY ASSESSED AS REPORTABLE DUE TO A DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME. RECENTLY, THE INCIDENT HAS BEEN REEVALUATED AS ACCORDING TO THE MEDICAL EXPERT'S ASSESSMENT, THE PROCEDURAL DELAY DID NOT HAVE ANY MAJOR CLINICAL RELEVANCE IN THIS SITUATION. THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371174 ↗
• MalfunctionDec 15, 2023Degraded; Use of Device Problem; Unintended Movement; Degraded; Use of Device Problem; Unintended Movement

  ON 27TH NOVEMBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 118001B2 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED. AS IT WAS STATED, TABLE TOP DROPPED AT THE BEGINNING OF THE SURGERY. THE MOVEMENT WAS INVOLUNTARY AND RAPID, HOWEVER, THE PATIENT'S POSITION DID NOT NEED TO BE CHANGED. THE 5/3 VALVE WAS FOUND TO BE DEFECTIVE. WE DECIDED TO REPORT THE ISSUE, NAMELY THE INTERRUPTION OF SURGERY, WHICH DEPENDING ON PATIENT CONDITIONS COULD LEAD TO SERIOUS INJURY IN CASE OF EVENT REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333933 ↗
• MalfunctionDec 8, 2023Degraded; Positioning Failure; Use of Device Problem; Degraded; Positioning Failure; Use of Device Problem

  ON 20TH NOVEMBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 118001B2 HYBRID OR TABLE COLUMN, SURFACE-MOUNTED. AS IT WAS STATED, AT 14:15 ON (B)(6), 2023, THE CARDIAC SURGERY DEPARTMENT PERFORMED A THORACIC AORTIC PERITONEAL STENT INTERVENTIONAL SURGERY ON THE PATIENT FOR AORTIC DISSECTION. AT 14:30, DURING LONGITUDINAL SHIFT TOWARDS THE HEAD SIDE, THE TABLE TOP SUDDENLY DROPPED AND LOST BALANCE LEADING TO THE TABLE CONTROL FAILURE. THE ISSUE RESULTED IN 10 MINUTE INTERRUPTION OF THE PROCEDURE. AFTER CONTACTING THE HOSPITAL'S MAINTENANCE ENGINEER TO RESTART THE EQUIPMENT, THE BED RETURNED TO LEVEL AND THE OPERATION CONTINUED TO BE COMPLETED. THE REMAINING OPERATIONS OF THE DAY WERE POSTPONED. THE INCIDENT WAS INITIALLY ASSESSED AS REPORTABLE DUE TO THE INTERRUPTION OF SURGERY. RECENTLY, THE RECORD HAS BEEN REEVALUATED. ACCORDING TO THE PERFORMED REVIEW, THE INFORMATION REGARDING THE INITIAL OCCURRENCE OF THE MALFUNCTION ON THIS DEVICE WAS RECEIVED IN APRIL 2023 AND REPORTED UNDER MANUFACTURER¿S REFERENCE NUMBER: (B)(4) (REPORT NUMBER: 8010652-2023-00134). BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE CUSTOMER DID NOT ACCEP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18289542 ↗
• MalfunctionDec 8, 2023Degraded; Positioning Failure; Degraded; Positioning Failure

  ON 20TH APRIL 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS ¿ 118001B2 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED USED WITH 118090A0 CABLE-CONNECTED HAND CONTROL AND 118016A1 - MAGNUS CARBON-FIBRE TABLE TOP,165 CM, EU. AS IT WAS INITIALLY REPORTED, OCCASIONAL OPERATING TABLE ERRORS WERE OCCURRING. FOLLOWING THE SERVICE VISIT ON SITE, DOUBLE CHECK VALVE, 5/3 VALVE OF THE COLUMN AND POTENTIOMETER OF TABLE TOP AND CABLE-CONNECTED HAND CONTROL WERE QUOTED TO THE CUSTOMER. ON 20TH NOVEMBER 2023, ADDITIONAL INFORMATION HAS BEEN RECEIVED. ACCORDING TO THE PROVIDED CUSTOMER INVESTIGATION, THE ISSUES OCCURRED DURING LIVER TUMOR PERFUSION CHEMOEMBOLIZATION. THE TABLE DROPPED WHILE MOVING THE TABLE TOP TO THE HEAD SIDE RESULTING IN LOST POSITION OF THE TABLE AND INABILITY TO MOVE THE DEVICE. THE ISSUE LED TO SUSPENSION OF THE OPERATION AND A DELAY OF 11 MINUTES. AFTER CONTACTING THE MAINTENANCE ENGINEER TO RESTART THE EQUIPMENT, THE TABLE WAS RESTORED TO ITS LEVEL AND THE OPERATION WAS COMPLETED. THE REST OF THE DAY'S OPERATIONS HAD TO BE POSTPONED. THE INCIDENT WAS INITIALLY ASSESSED AS REPORTABLE DUE TO THE INTERRUPTION OF SURGERY LEADING TO A PROCEDURAL DELAY. RECENTLY, THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18289414 ↗
• MalfunctionDec 7, 2023Degraded; Positioning Failure; Use of Device Problem; Degraded; Positioning Failure; Use of Device Problem

  ON 7TH OCTOBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 118001B2 HYBRID OR TABLE COLUMN, SURFACE-MOUNTED USED WITH 118016A1 - MAGNUS CARBON-FIBRE TABLE TOP,185 CM, EU. ACCORDING TO INITIALLY PROVIDED INFORMATION, DURING LONGITUDINAL SHIFT THE TABLE TOP MOVED TO A CERTAIN POSITION AND ONE SIDE OF THE TABLE TOP DROPPED BY 2-3 CM RESULTING IN LOST POSITION OF THE TABLE AND INABILITY TO MOVE THE DEVICE. AS IT WAS STATED, THE ISSUE OCCURRED DURING PREOPERATIVE PREPARATION AND PATIENT WAS ON THE OPERATING TABLE, HOWEVER, WAS NOT UNDER ANESTHESIA. AFTER SUSPENDING THE OPERATION FOR APPROXIMATELY 15 MINUTES, THE EQUIPMENT WAS RESTARTED AND THE PROCEDURE CONTINUED. ON 20TH NOVEMBER 2023, ADDITIONAL INFORMATION WAS RECEIVED. ACCORDING TO INFORMATION PROVIDED IN CUSTOMER INVESTIGATION, THE INCIDENT OCCURRED DURING UPPER EXTREMITY ARTERIAL THROMBECTOMY. THE REST OF THE DAY'S OPERATIONS HAD TO BE POSTPONED. THE INCIDENT WAS INITIALLY ASSESSED AS REPORTABLE DUE TO INTERRUPTION OF SURGERY LEADING TO A PROCEDURAL DELAY. RECENTLY, THE INCIDENT HAS BEEN REEVALUATED AS ACCORDING TO THE MEDICAL EXPERT'S ASSESSMENT, THE PROCEDURAL DELAY DID NOT HAVE ANY MAJOR CLINICAL RELEVANCE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18281887 ↗
• MalfunctionOct 23, 2023Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem

  ON 12TH OCTOBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 118001B2 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED USED WITH 1180.16 TABLE TOP AND SIEMENS ARTIS PHENO AND CT SCAN DEVICES DURING CRANIOTOMY. AS IT WAS STATED, FOLLOWING USE OF THE MAGNUS HYBRID SYSTEM WITH ANGIOGRAPHY DEVICE, THE STAFF NEEDED TO PERFORM CT SCAN WHICH REQUIRED CHANGE IN THE HEIGHT OF THE COLUMN. ACCORDING TO THE PROVIDED INFORMATION HEIGHT ADJUSTMENT COULD NOT BE DONE LEADING TO A DELAY IN THE PROCEDURE ON THE ANESTHETIZED PATIENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17982862 ↗
• MalfunctionSep 19, 2023Degraded; Use of Device Problem; Unintended Movement; Degraded; Use of Device Problem; Unintended Movement

  ON 4TH SEPTEMBER 2023 GETINGE BECAME AWARE OF A SITUATION WITH ONE OF OUR COLUMNS ¿ 118001B2 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED. AS IT WAS STATED, DURING LOWER LIMB ARTERIOGRAPHY TREATMENT, WHEN THE OPERATING TABLE WAS MOVED TO A CERTAIN POSITION ALONG THE LONG AXIS, FAST UNINTENDED DOWN MOVEMENT (1-2 CM) OF ONE END OF THE TABLE OCCURRED. THE COLUMN WAS RESET AND THE SURGERY WAS CONTINUED. THE PATIENT WAS ANESTHETIZED. THE ISSUE DID NOT LED TO A DELAY IN TREATMENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY FAST UNINTENDED MOVEMENT OF THE OPERATING TABLE DURING SURGERY, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772337 ↗
• MalfunctionSep 14, 2023Computer Software Problem; Communication or Transmission Problem; Computer Software Problem; Communication or Transmission Problem

  ON (B)(6) 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 118001B2 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED USED WITH SIEMENS ANGIOGRAPHY SYSTEM. AS IT WAS STATED, THE ANGIOGRAPHY DEVICE DID NOT RUN AT THE ¿REDUCED STANDBY SPEED¿ AND THE TABLE COULD NO LONGER BE MOVED. THE BED WAS MAXIMALLY RAISED FOR THE TRANSFER OF THE PATIENT WHICH MADE IT DIFFICULT FOR THE STAFF. ON (B)(6) 2023, THE CONFIRMATION WAS RECEIVED THAT THE ISSUE LED TO A DELAY IN THE PROCEDURE ON THE ANESTHETIZED PATIENT. ADDITIONALLY, ACCORDING TO THE PROVIDED INFORMATION, THE NEXT PATIENT WAS WAITING IN FRONT OF THE ROOM FOR OVER AN HOUR DUE TO THE ISSUE. THERE WAS NO INJURY OF THE PATIENT REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE AS A DELAY OF SURGERY, RESULTING IN PROLONGED ANESTHESIA TIME, COULD LEAD TO SERIOUS INJURY IN CASE OF EVENT RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744602 ↗
• MalfunctionSep 14, 2023Computer Software Problem; Communication or Transmission Problem; Computer Software Problem; Communication or Transmission Problem

  ON (B)(6) 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 118001B2 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED USED WITH SIEMENS ANGIOGRAPHY SYSTEM. FURTHER CLARIFICATIONS WERE REQUIRED TO ESTABLISH THE COURSE OF EVENTS. AS IT WAS STATED, TOWARDS THE END OF THE PROCEDURE, THE SIEMENS ANGIOGRAPHY SYSTEM LOCKED ABOVE THE PATIENT WITH THE MESSAGE THAT THE TABLE WAS NO LONGER RECOGNIZED. IT WAS NOT POSSIBLE TO REMOVE ANGIOGRAPHY DEVICE EVEN WITH USE OF THE EMERGENCY CARDIAC RESUSCITATION FUNCTION. ACCORDING TO THE PROVIDED INFORMATION, THE SURGERY WAS COMPLETED DESPITE POOR CONDITIONS, HOWEVER, IT WAS DIFFICULT TO GET THE PATIENT BACK INTO BED. ON (B)(6) 2023, THE CONFIRMATION WAS RECEIVED THAT THE ISSUE LED TO A DELAY IN THE PROCEDURE ON THE ANESTHETIZED PATIENT. THERE WAS NO INJURY OF THE PATIENT REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE AS A DELAY OF SURGERY, RESULTING IN PROLONGED ANESTHESIA TIME, COULD LEAD TO SERIOUS INJURY IN CASE OF EVENT RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744462 ↗
• MalfunctionSep 14, 2023Computer Software Problem; Communication or Transmission Problem; Computer Software Problem; Communication or Transmission Problem

  ON 6TH SEPTEMBER 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 118001B2 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED USED WITH SIEMENS ANGIOGRAPHY SYSTEM. AS IT WAS STATED, THE OPERATING TABLE AND ANGIOGRAPHY SYSTEM STOPPED MOVING, AND IT WAS IMPOSSIBLE TO LOWER THE TABLE TO TRANSFER THE PATIENT TO BED. THE REMOTE CONTROL INDICATED "COLLISION WITH ANGIOGRAPH". THE STAFF PRESSED THE "?" BUTTON WHICH ALLOWED TO MOVE THE ANGIOGRAPHY DEVICE VERY SLOWLY AWAY FROM THE PATIENT, HOWEVER, THE SYSTEM INDICATED "RISK OF COLLISION" THROUGHOUT. WHEN THE ANGIOGRAPHY DEVICE WAS AWAY FROM THE PATIENT IT WAS POSSIBLE TO MOVE THE TABLE TO COMPLETE THE TRANSFER. ON 8TH SEPTEMBER 2023, THE CONFIRMATION WAS RECEIVED THAT THE ISSUE LED TO A DELAY IN THE PROCEDURE ON THE ANESTHETIZED PATIENT. THERE WAS NO INJURY OF THE PATIENT REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE AS A DELAY OF SURGERY, RESULTING IN PROLONGED ANESTHESIA TIME, COULD LEAD TO SERIOUS INJURY IN CASE OF EVENT RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744025 ↗
• MalfunctionSep 14, 2023Device Sensing Problem; Device Sensing Problem

  ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS ¿ 118001B2 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED USED WITH SIEMENS ANGIOGRAPHY SYSTEM. AS IT WAS STATED, A VERTICAL POSITION ERROR OCCURRED DURING SURGERY WHILE A HYBRID COLUMN WAS INTERLOCKING WITH ANGIOGRAPHY DEVICE. ACCORDING TO THE PROVIDED INFORMATION, THE HEIGHT VALUES WERE NOT DISPLAYED. THE ISSUE LED TO A DELAY OF APPROXIMATELY 5 TO 10 MINUTES IN THE PROCEDURE ON ANESTHETIZED PATIENT. THERE WAS NO INJURY OF THE PATIENT REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE AS A DELAY OF SURGERY, RESULTING IN PROLONGED ANESTHESIA TIME, COULD LEAD TO SERIOUS INJURY IN CASE OF EVENT RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17743026 ↗
• MalfunctionSep 12, 2023Failure to Sense; Communication or Transmission Problem; Failure to Sense; Communication or Transmission Problem

  ON 1ST SEPTEMBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS ¿ 118001B2 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED USED WITH SIEMENS ARTIS Q ZEEGO C-ARM DURING PACEMAKER EXTRACTION. AS IT WAS STATED, C-ARM AND TABLE WERE NOT MOVING DUE TO A COMMUNICATION ISSUE. ACCORDING TO THE PROVIDED INFORMATION, BOTH DEVICES WERE RESTARTED AND THE SURGERY COULD BE CONTINUED. THE ISSUE LED TO A DELAY IN THE PROCEDURE. THERE WAS NO INJURY OF THE PATIENT REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE AS A DELAY OF SURGERY, RESULTING IN PROLONGED ANESTHESIA TIME, COULD LEAD TO SERIOUS INJURY IN CASE OF EVENT RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17732993 ↗
• MalfunctionMar 16, 2023Computer Software Problem; Positioning Problem; Computer Software Problem; Positioning Problem

  ON 17TH FEBRUARY 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 118001B2 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED USED WITH SIEMENS ANGIOGRAPHY SYSTEM. AS IT WAS STATED, MAGNUS HYBRID SYSTEM STOPPED WORKING DURING A SURGERY ON THE ANESTHETIZED PATIENT. ACCORDING TO THE PROVIDED INFORMATION, THE SURGERY ENDED WHEN THE INCIDENT OCCURRED AND THE PATIENT WAS TRANSFERRED TO BED WITH DIFFICULTY. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION BASED ON POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY MAGNUS HYBRID SYSTEM NOT WORKING DURING SURGERY WHICH COULD POTENTIALLY LEAD TO DELAY IN TREATMENT AND PROLONGED ANESTHESIA TIME, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16559653 ↗