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| Model Number 118016A1 |
| Device Problem
Positioning Failure (1158)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 09/20/2023 |
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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.E1c event site address: (b)(6).E1h event site postal code: (b)(6).H3 other text : device not returned to manufacturer.
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Event Description
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On (b)(6) 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 system got stuck and the table top could not be moved which was accompanied by an alarm sound.The issue affected the process of emergency surgery on anesthetized patient and may have resulted in 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 inability to position patient as required during emergency procedure and the delay in surgery resulting in prolonged anesthesia time, was to reoccur.
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Event Description
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On 6th december 2023 getinge became aware of an issue with one of our table tops - 118016a1 - magnus carbon-fibre table top,185 cm, eu used with 118001b2 - hybrid or table column, surface-mounted.As it was stated, the operating table system got stuck and the table top could not be moved which was accompanied by an alarm sound.The issue affected the process of emergency surgery on anesthetized patient and may have resulted in 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 inability to position patient as required during emergency procedure and the delay in surgery resulting in prolonged anesthesia time, was to reoccur.
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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 6th 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 system got stuck and the table top could not be moved which was accompanied by an alarm sound.The issue affected the process of emergency surgery on anesthetized patient and may have resulted in 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 inability to position patient as required during emergency procedure and the delay in surgery resulting in prolonged anesthesia time, was to reoccur.Corrected b5 describe event or problem: on 6th december 2023 getinge became aware of an issue with one of our table tops - 118016a1 - magnus carbon-fibre table top,185 cm, eu used with 118001b2 - hybrid or table column, surface-mounted.As it was stated, the operating table system got stuck and the table top could not be moved which was accompanied by an alarm sound.The issue affected the process of emergency surgery on anesthetized patient and may have resulted in 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 inability to position patient as required during emergency procedure and the delay in surgery resulting in prolonged anesthesia time, was to reoccur.Previous d1 brand name: hybrid or table column, surface-mounted.Corrected d1 brand name: magnus carbon-fibre table top,185 cm, eu.Previous d2 common device name: fqo table, operating-room, ac-powered.Corrected d2 common device name: kxj table, radiologic.Previous d4 version or model #: 118001b2.Corrected d4 version or model #: 118016a1.Previous d4 catalog #: 118001b2.Corrected d4 catalog #: 118016a1.Previous d4 serial #: (b)(6).Corrected d4 serial #: (b)(6).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: 10/01/2019.Corrected h4 device manufacture date: 04/30/2019.
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Event Description
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On 6th december 2023, getinge became aware of an issue with one of our table tops - 118016a1 - magnus carbon-fibre table top,185 cm, eu used with 118001b2 - hybrid or table column, surface-mounted.As it was stated, the operating table system got stuck and the table top could not be moved which was accompanied by an alarm sound.The issue affected the process of emergency surgery on anesthetized patient and may have resulted in 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 the inability to position the patient as required during the emergency procedure, was to reoccur.
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Manufacturer Narrative
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On 6th december 2023 getinge became aware of an issue with one of our table tops - 118016a1 - magnus carbon-fibre table top,185 cm, eu used with 118001b2 - hybrid or table column, surface-mounted.As it was stated, the operating table system got stuck and the table top could not be moved which was accompanied by an alarm sound.The issue affected the process of emergency surgery on anesthetized patient and may have resulted in 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 inability to position patient as required during emergency procedure, was to reoccur.With the investigation performed it was concluded that upon the event occurrence, the devices were being used for the patient¿s treatment, and thus were also directly involved with the reported incident.As the table top¿s malfunction was found, it was considered that the getinge device failed to meet its specifications.A review of the received customer product complaints revealed that in the past there was no serious injury to the patient or user when this particular issue occurred.There were two additional reportable customer product complaints registered for the 118016a1 magnus carbon-fibre table top with serial number (b)(6).The complaints were assessed as related to the reported issue.Comparing the number of complained devices to the number of investigated magnus carbon fibre table tops on the market we can conclude the failure ratio is (b)(4)% for the issue investigated herein.Comparing the number of complained devices to the number of 118016 carbon fibre table tops and 118001 columns on the market we can conclude the failure ratio for configuration is (b)(4)% for the issue investigated herein.It has been documented that the devices were installed in december 2019.After the warranty period, the hospital's equipment maintenance was overall managed by a third-party company, so this equipment was repaired by the third-party company itself.Although there is a fault, the third-party after-sales maintenance company has not performed repairs.The customer removed the fuse, reset and turned the device on and stated that the operating table could temporarily run normally.According to the ssu, the third-party company did not provide adequate service and maintenance in the past and made it impossible for getinge to intervene.The ssu stated that the customer was ready to purchase a getinge maintenance contract, however, as public bidding is required there was no written quotation.The written contract can be provided after the bidding is completed.It is the internal working flow on the customer side, nobody can interrupt and involved.The affected devices were inspected by the getinge service technician.The technician has confirmed a malfunction of the carbon fibre table top.The longitudinal drive (component number 2011502) was found to be defective.The component was quoted and a getinge maintenance plan was offered, however after the temporary calibration work carried out in december 2023, the equipment could be used normally for the time being and the customer may give up the subsequent repair or maintenance plan.The subject matter expert (sme) at the manufacturing site analyzed the device¿s error.The error log was full of sensor errors in the table top (lengthwise/crosswise).Unfortunately, the logs provided did not include the timeframe when the investigated issue occurred.No additional logs were available.Based on the available information the manufacturer could not perform a more in-depth investigation.In the instructions for use (ga 1180.16 en 09, page 71), the user is informed that a defective product may not be used and may not be repaired by themselves.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 inability to position the patient as required during the procedure, is related to the insufficient and inadequate service provided by the third-party company.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 b5 describe event or problem and h6 health effect ¿ impact codes fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 6th december 2023 getinge became aware of an issue with one of our table tops - 118016a1 - magnus carbon-fibre table top,185 cm, eu used with 118001b2 - hybrid or table column, surface-mounted.As it was stated, the operating table system got stuck and the table top could not be moved which was accompanied by an alarm sound.The issue affected the process of emergency surgery on anesthetized patient and may have resulted in 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 inability to position patient as required during emergency procedure and the delay in surgery resulting in prolonged anesthesia time, was to reoccur.Corrected b5 describe event or problem: on 6th december 2023, getinge became aware of an issue with one of our table tops - 118016a1 - magnus carbon-fibre table top,185 cm, eu used with 118001b2 - hybrid or table column, surface-mounted.As it was stated, the operating table system got stuck and the table top could not be moved which was accompanied by an alarm sound.The issue affected the process of emergency surgery on anesthetized patient and may have resulted in 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 the inability to position the patient as required during the emergency procedure, was to reoccur.Previous h6 health effect ¿ impact codes: surgical intervention|prolonged surgery||4632.Corrected h6 health effect ¿ impact codes: no health consequences or impact|||2199.
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