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| Model Number 118016A6 |
| Device Problem
Positioning Problem (3009)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 07/28/2022 |
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Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
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Event Description
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On (b)(6) 2022 getinge became aware of an issue with one of our table tops ¿ 118016a6 - cfk-table top magnus, 205 cm, bolus, eu.As it was stated, during the pretreatment stage of neurosurgical endovascular surgery, the 118016a6 - cfk-table top magnus, 205 cm, bolus, eu was used with 118001b2 - hybrid or table column, surface-mounted.The error 174/9 "error during position detection" was displayed.Transfer of patient to another table top was required which resulted in a delay of approximately an hour and a half.The patient was already under anesthesia.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.
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Manufacturer Narrative
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According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The correction of b5 describe event or problem field deems required.This is based on the additional information that has been received.Previous b5 describe event or problem: on (b)(6) 2022 getinge became aware of an issue with one of our table tops ¿ 118016a6 - cfk-table top magnus, 205 cm, bolus, eu.As it was stated, during the pretreatment stage of neurosurgical endovascular surgery, the 118016a6 - cfk-table top magnus, 205 cm, bolus, eu was used with 118001b2 - hybrid or table column, surface-mounted.The error 174/9 "error during position detection" was displayed.Transfer of patient to another table top was required which resulted in a delay of approximately an hour and a half.The patient was already under anesthesia.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.Corrected b5 describe event or problem: on (b)(6) 2022 getinge became aware of an issue with one of our table tops ¿ 118016a6 - cfk-table top magnus, 205 cm, bolus, eu.As it was stated, during the pretreatment stage of neurosurgical endovascular surgery, the 118016a6 - cfk-table top magnus, 205 cm, bolus, eu was used with 118001b2 - hybrid or table column, surface-mounted.During docking with the table, the error 174/9 "error during position detection" was displayed preventing operations of longitudinal sliding, tilt shift, and trendelenburg positioning.Transfer of patient to another table top was required which resulted in a delay of approximately an hour and a half.The patient was already under anesthesia.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.
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Event Description
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On (b)(6) 2022 getinge became aware of an issue with one of our table tops ¿ 118016a6 - cfk-table top magnus, 205 cm, bolus, eu.As it was stated, during the pretreatment stage of neurosurgical endovascular surgery, the 118016a6 - cfk-table top magnus, 205 cm, bolus, eu was used with 118001b2 - hybrid or table column, surface-mounted.During docking with the table, the error 174/9 "error during position detection" was displayed preventing operations of longitudinal sliding, tilt shift, and trendelenburg positioning.Transfer of patient to another table top was required which resulted in a delay of approximately an hour and a half.The patient was already under anesthesia.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.
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Manufacturer Narrative
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According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.
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Event Description
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Manufacturer's reference number (b)(4).
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Event Description
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Manufacturer's reference number (b)(4).
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Manufacturer Narrative
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Getinge became aware of an issue with one of our table tops ¿ 118016a6 - cfk-table top magnus, 205 cm, bolus, eu.The issue occurred during the pretreatment stage of neurosurgical endovascular surgery, the table top was used with 118001b2 - hybrid or table column, surface-mounted.The error 174/9 was displayed.Transfer of patient to another table top was required which resulted in a delay of approximately an hour and a half.The patient was already under anesthesia.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.The affected getinge device has been evaluated by the company¿s services technicians.The technicians confirmed the malfunction of the table top.Defective parts were returned for further evaluation at the manufacturing site.The root cause analysis has been performed by the process assurance team.The following parts have been assessed: two longitudinal drives, longitudinal potentiometer, micro switch, control unit for table top, column controller unit and contact module.The longitudinal drive with serial number (b)(6) had a crushed cable.The spiral cable also was damaged.According to the process assurance team, the crushed cable or the damage to the spiral cable should have no effect on error 174/9.Therefore, it has been assessed that there was no issue with motor¿s functionality.Other parts have also been tested and some of them have been sent to suppliers for evaluation.None of the tests performed resulted in finding any malfunctions with returned parts.This complaint was a fourth claimed for the position error issue of aforementioned carbon fibre table top.All previous malfunctions has been solved either by realignment of the table top, replacing longitudinal potentiometer, drive and control unit, which were in use for more than five years by the time of the issue occurrence or another renewal of longitudinal potentiometer with a suspect of initial defect caused by the supplier and longitudinal drive with visible signs of misuse.The issue investigated herein was the first one, which occurred during surgery.The subject matter expert at the manufacturing site was contacted for the support with the root cause assessment.According to the sme¿s assessment, the most likely root cause for the issue occurrence might be a repair not being carried out properly.If the sensor is not set correctly to the end position it could be that the potentiometer is working at its outer range of its tolerance.The service technician was reminded to perform all repairs in accordance to service manuals and procedures approved by the manufacturer.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment, thus was also directly involved with the reported incident.As the malfunction of several parts was found, it was considered that the getinge device was not up to the specification.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 h4 device manufacture date, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain, h6 component codes fields deems required.This is based on the internal evaluation.Previous h4 device manufacture date: 08/15/2016.Corrected h4 device manufacture date: 08/19/2016.Previous h3a device evaluated by manufacturer: no (attach page to explain why not or provide code).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 h6 component codes: measurement|sensor||510.Electrical and magnetic|circuit board||427.Mechanical|motor(s)||486.Corrected h6 component codes: measurement|sensor||510.
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