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On 13th march 2024, getinge became aware of an issue with one of our columns - 118001d0 - magnus or-table column, indepen.As it was stated, the operating table could no longer be moved to 0 position from the lateral tilting of the table during a surgery on an anesthetized patient.The motors could be heard very quietly, however, there was no movement in the modules.If the modules were controlled separately, they worked with a delay.No error message was displayed on the remote control.The emergency panel did not work as well.After approximately 10 minutes from the last maneuver, the tilting could be cancelled by remote control, however, it was still impossible to move the table into 0 position.At the time of incident, the table base was connected to the power supply.The issue resulted in a delay as the patient could not be positioned properly.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if situations, namely operating table not responding to remote control nor override panel leading to inability to position the patient as required and the delay in surgery resulting in prolonged anesthesia time, were to reoccur.
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On 13th march 2024, getinge became aware of an issue with one of our columns - 118001d0 - magnus or-table column, indepen.As stated, the operating table could no longer be moved to the 0 position from the lateral tilt during surgery on an anesthetized patient.The motors were heard faintly, but there was no movement in the modules.When controlled separately, the modules operated with a delay.No error message was displayed on the remote control, and the emergency panel also failed to function.Approximately 10 minutes after the last maneuver, the tilt was able to be canceled using the remote control, however, it was still impossible to return the table to the 0 position.At the time of the incident, the table base was connected to the power supply.This issue caused a delay, as the patient could not be properly positioned.While no injury was reported, we decided to report the incident due to the potential for serious injury if the situation were to reoccur, namely the operating table not responding to the remote control or the override panel, leading to the inability to position the patient as required.
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Getinge became aware of an issue with one of our columns - 118001d0 - magnus or-table column, indepen.As stated, the operating table could no longer be moved to the 0 position from the lateral tilt during surgery on an anesthetized patient.The motors were heard faintly, but there was no movement in the modules.When controlled separately, the modules operated with a delay.No error message was displayed on the remote control, and the emergency panel also failed to function.Approximately 10 minutes after the last maneuver, the tilt was able to be canceled using the remote control, however, it was still impossible to return the table to the 0 position.At the time of the incident, the table base was connected to the power supply.This issue caused a delay, as the patient could not be properly positioned.While no injury was reported, we decided to report the incident due to the potential for serious injury if the situation were to reoccur, namely the operating table not responding to the remote control or the override panel, leading to the inability to position the patient as required.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment, and thus were also directly involved with the reported incident.As the column¿s malfunction was found, it was considered that the getinge device failed to meet its specifications.Comparing the number of devices involved in the adverse event to the amount of magnus table column placed on the market we can conclude the failure ratio is 0.16% for the issue investigated herein.The technician has evaluated the affected getinge device and identified a fault in the hydraulic pump.After the hydraulic unit (part number 31150329) was replaced, the system was purged, operational tests were conducted, and the device was returned to usage.The wear of the hydraulic unit was investigated during capa 2019-006 ((b)(4)) due to carbon abrasion of the brushes within the motor housing.The root cause identified in the capa was linked to design development.Malfunctions of the hydraulic units were addressed through a service assignment initiated to resolve customer complaints.The issue regarding the lifespan of hydraulic units in 1180 columns is currently under investigation under capa 2024-009 ((b)(4)).These units have an expected lifespan of 4 years.However, the repair and service manuals provided to customers do not specify a mandatory replacement after 4 years, but instead recommend inspection and replacement if necessary.According to the maintenance manual (tw (b)(4) rev 06, page 40), the useful lifetime of the hydraulic unit varies depending on its intensity and extent of application.To ensure continued availability of the product, the manufacturer recommends checking the hydraulic units every 4 years and replacing them if necessary.The first hydraulic issue with the affected column was reported two months prior to the incident under investigation.The affected column was manufactured on 03/04/2013 and had been in use for over 10 years at the time of the event.According to the risk management plan (rmp 1134475 rev 03, page 3), the expected service life of the column is 10 years.The device's age likely contributed to the issue.In summary and as a result of the performed root cause evaluation, it was concluded that based on available information it can be suspected that the most probable root cause of the reported issue, namely the operating table not responding to the remote control or the override panel, leading to the inability to position the patient as required is related to the expected wear and tear.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) #, h4 device manufacture date fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 13th march 2024, getinge became aware of an issue with one of our columns - 118001d0 - magnus or-table column, indepen.As it was stated, the operating table could no longer be moved to 0 position from the lateral tilting of the table during a surgery on an anesthetized patient.The motors could be heard very quietly, however, there was no movement in the modules.If the modules were controlled separately, they worked with a delay.No error message was displayed on the remote control.The emergency panel did not work as well.After approximately 10 minutes from the last maneuver, the tilting could be cancelled by remote control, however, it was still impossible to move the table into 0 position.At the time of incident, the table base was connected to the power supply.The issue resulted in a delay as the patient could not be positioned properly.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if situations, namely operating table not responding to remote control nor override panel leading to inability to position the patient as required and the delay in surgery resulting in prolonged anesthesia time, were to reoccur.Corrected b5 describe event or problem: on 13th march 2024, getinge became aware of an issue with one of our columns - 118001d0 - magnus or-table column, indepen.As stated, the operating table could no longer be moved to the 0 position from the lateral tilt during surgery on an anesthetized patient.The motors were heard faintly, but there was no movement in the modules.When controlled separately, the modules operated with a delay.No error message was displayed on the remote control, and the emergency panel also failed to function.Approximately 10 minutes after the last maneuver, the tilt was able to be canceled using the remote control; however, it was still impossible to return the table to the 0 position.At the time of the incident, the table base was connected to the power supply.This issue caused a delay, as the patient could not be properly positioned.While no injury was reported, we decided to report the incident due to the potential for serious injury if the situation were to reoccur, namely the operating table not responding to the remote control or the override panel, leading to the inability to position the patient as required.Previous d1 brand name: magnus or-table column, indepen.Corrected d1 brand name: magnus operating table system.Previous d4 catalog #: 118001d0.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 h4 device manufacture date: 03/01/2013.Corrected h4 device manufacture date: 03/04/2013.
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