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On (b)(6) 2024 getinge became aware of an issue with one of our table tops - 118010a0 - basis table top,individual configuration used with 118001c0 - magnus table column, mobile.The received customer allegation regarded a non-reportable issue.On (b)(6) 2024, additional information was received.As it was stated, the unintended movement of the table top occurred during the intraoperative phase of laparoscopic diagnostics and possible hernia repair with mesh insert on the anesthetized patient.The incision had already been made at the time of incident.The operating table moved in the opposite direction than indicated (desired movement: trendelenburg position, tilting to the right; actual movement: anti-trendelenburg position, tilting to the left).Following the unintended motion, the buttons on the remote control did not work and the table top could not be moved for 30 minutes which made the diagnosis extremely difficult for the surgeon.The operation could not be completed and was ended early.The patient had to remain under anesthesia for 10 more minutes as the table still could not be moved.After that time, the table worked again and the anesthesia could be ended.According to the service technician, the following errors were found in the memory of the device: error 31 (column) and error 35 (table top).There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situations, namely the unintended movement of the table top during the procedure, inability to position the patient as required resulting in initially suboptimal treatment that may have to be corrected subsequently and delay in surgery resulting in prolonged anesthesia time, were to reoccur.
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On 17th january 2024 getinge became aware of an issue with one of our tabletops - 118010a0 - basis tabletop, individual configuration used with 118001c0 - magnus table column, mobile.The received customer allegation regarded a non-reportable issue.On 26th january 2024, additional information was received.As it was stated, the unintended movement of the tabletop occurred during the intraoperative phase of laparoscopic diagnostics and possible hernia repair with mesh insert on the anesthetized patient.The incision had already been made at the time of incident.The operating table moved in the opposite direction than indicated (desired movement: trendelenburg position, tilting to the right; actual movement: anti-trendelenburg position, tilting to the left).Following the unintended motion, the buttons on the remote control did not work and the tabletop could not be moved for 30 minutes which made the diagnosis extremely difficult for the surgeon.The operation could not be completed and was ended early.The patient had to remain under anesthesia for 10 more minutes as the table still could not be moved.After that time, the table worked again and the anesthesia could be ended.According to the service technician, the following errors were found in the memory of the device: error 31 (column) and error 35 (tabletop).There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situations, namely the unintended movement of the tabletop during the procedure, inability to position the patient as required resulting in procedural delay and initially suboptimal treatment that may have to be corrected subsequently, were to reoccur.
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Getinge became aware of an issue with one of our table tops - 118010a0 - basis table top,individual configuration used with 118001c0 - magnus table column, mobile.The received customer allegation regarded a non-reportable issue.On 26th january 2024, additional information was received.As it was stated, the unintended movement of the table top occurred during the intraoperative phase of laparoscopic diagnostics and possible hernia repair with mesh insert on the anesthetized patient.The incision had already been made at the time of incident.The operating table moved in the opposite direction than indicated (desired movement: trendelenburg position, tilting to the right; actual movement: anti-trendelenburg position, tilting to the left).Following the unintended motion, the buttons on the remote control did not work and the table top could not be moved for 30 minutes which made the diagnosis extremely difficult for the surgeon.The operation could not be completed and was ended early.The patient had to remain under anesthesia for 10 more minutes as the table still could not be moved.After that time, the table worked again and the anesthesia could be ended.According to the service technician, the following errors were found in the memory of the device: error 31 (column) and error 35 (table top).There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situations, namely the unintended movement of the table top during the procedure, inability to position the patient as required resulting in procedural delay and initially suboptimal treatment that may have to be corrected subsequently, were to reoccur.The affected device was evaluated by a getinge technician, who confirmed the malfunction of the table.Error log was checked, revealing multiple occurrences of error 31 and error 35.As a precaution, the optics and contact module were replaced (9704653), as the interface between the column and table top was identified as the likely cause of the issue.The technician adjusted and recalibrated the operating table in service mode.All functions were tested, and no further malfunctions were observed.Safety test (stk) measurements were performed, and all values were within the permissible range.The technician successfully carried out the necessary repairs, ensuring the devices were restored to full working order and returned to service.Based on the investigation, it was concluded that at the time of the incident, the devices were being used for the patient's treatment and therefore were directly involved in the reported event.Since the operating table malfunction occurred, it was determined that the getinge devices failed to perform according to their specified functions.A review of the received customer product complaints revealed that there were no injuries to a user nor to a patient or operator when this particular incident occurred.There is a maintenance contract for 2023 where the maintenance was also carried out on 11th september 2023.No disruptions were detected during mentioned maintenance.The affected devices were manufactured in 2011 and had been in use for over 12 years at the time of the event.According to the risk management plan (risk management plan _ lagerflaeche cepg.0118, page 3), the expected service life of the table top is 10 years.Initially, the malfunction was attributed to the device's age.However, considering previous complaints of similar issues wear and tear on those parts cannot be identified as the primary cause of the issue.Since we could not identify the specific reason for the issue, the root cause remains unknown and impossible to define.We currently do not have any information that would warrant further action regarding 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 full unique identifier (udi) # information is not available since the device was manufactured before 09/24/2022.The correction of b5 describe event or problem, d1 brand name, d4 catalog #, d4 serial #, d4 unique identifier (udi) #, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code ¿ explain, h4 device manufacture date and h6 health effect ¿ clinical code fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 17th january 2024 getinge became aware of an issue with one of our table tops - 118010a0 - basis table top,individual configuration used with 118001c0 - magnus table column, mobile.The received customer allegation regarded a non-reportable issue.On 26th january 2024, additional information was received.As it was stated, the unintended movement of the table top occurred during the intraoperative phase of laparoscopic diagnostics and possible hernia repair with mesh insert on the anesthetized patient.The incision had already been made at the time of incident.The operating table moved in the opposite direction than indicated (desired movement: trendelenburg position, tilting to the right; actual movement: anti-trendelenburg position, tilting to the left).Following the unintended motion, the buttons on the remote control did not work and the table top could not be moved for 30 minutes which made the diagnosis extremely difficult for the surgeon.The operation could not be completed and was ended early.The patient had to remain under anesthesia for 10 more minutes as the table still could not be moved.After that time, the table worked again and the anesthesia could be ended.According to the service technician, the following errors were found in the memory of the device: error 31 (column) and error 35 (table top).There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situations, namely the unintended movement of the table top during the procedure, inability to position the patient as required resulting in initially suboptimal treatment that may have to be corrected subsequently and delay in surgery resulting in prolonged anesthesia time, were to reoccur.Corrected b5 describe event or problem: on 17th january 2024 getinge became aware of an issue with one of our table tops - 118010a0 - basis table top,individual configuration used with 118001c0 - magnus table column, mobile.The received customer allegation regarded a non-reportable issue.On 26th january 2024, additional information was received.As it was stated, the unintended movement of the table top occurred during the intraoperative phase of laparoscopic diagnostics and possible hernia repair with mesh insert on the anesthetized patient.The incision had already been made at the time of incident.The operating table moved in the opposite direction than indicated (desired movement: trendelenburg position, tilting to the right; actual movement: anti-trendelenburg position, tilting to the left).Following the unintended motion, the buttons on the remote control did not work and the table top could not be moved for 30 minutes which made the diagnosis extremely difficult for the surgeon.The operation could not be completed and was ended early.The patient had to remain under anesthesia for 10 more minutes as the table still could not be moved.After that time, the table worked again and the anesthesia could be ended.According to the service technician, the following errors were found in the memory of the device: error 31 (column) and error 35 (table top).There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situations, namely the unintended movement of the table top during the procedure, inability to position the patient as required resulting in procedural delay and initially suboptimal treatment that may have to be corrected subsequently, were to reoccur.Previous d1 brand name: basis table top,individual configuration.Corrected d1 brand name: basic table top.Previous d4 catalog #: 118010a0.Corrected d4 catalog #: n/a.Previous d4 serial #: (b)(6).Corrected d4 serial #: (b)(6).Previous d4 unique identifier (udi) #: n/a.Corrected d4 unique identifier (udi) #: (b)(4).Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: n/a.Previous h3c if other provide code - explain: device not returned to manufacturer.Corrected h3c if other provide code - explain: n/a.Previous h4 device manufacture date: 06/01/2011.Corrected h4 device manufacture date: 05/25/2011.Previous h6 health effect ¿ clinical code: surgical intervention|prolonged surgery||4632.Surgical intervention|additional surgery||4625.Corrected h6 health effect ¿ clinical code: delay to treatment/ therapy|||4604.Surgical intervention|additional surgery||4625.Previous h6 component codes: electrical and magnetic|circuit board||427.Corrected h6 component codes: measurement|sensor||510.
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