MAUDE Adverse Event Report: MAQUET GMBH MAGNUS CARBON-FIBRE TABLE TOP,185 CM, EU; TABLE, RADIOLOGIC

Model Number 118016A1

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.E1h event site postal code: (b)(6).H3 other text : device not returned to manufacturer.

Event Description

On (b)(6) 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 table top could not be moved during surgery, which affected the surgical procedure on the anesthetized patient.Restart of angiography device (dsa) and the operating table did not resolve the issue as the table top could be barely moved.It was estimated that there was a delay in the operation.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.

Event Description

On 7th 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 table top could not be moved during surgery, which affected the surgical procedure on the anesthetized patient.Restarting of angiography device (dsa) and the operating table did not resolve the issue as the table top could be barely moved.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 procedure, was to reoccur.

Manufacturer Narrative

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 angles of the operating table top could not be adjusted and the device could not be moved normally during surgery.The sluggish and slow movements affected the process of positioning of the anesthetized patient.The remote control could not have been used and the override panel of the operating table could have been barely used.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 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 restated the device and stated that it could be used normally, however, the longitudinal movement was still stuck.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, 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 ¿ impact codes fields deems required.This is based on the internal evaluation and additional information that has been received.Previous b5 describe event or problem: on 7th 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 table top could not be moved during surgery, which affected the surgical procedure on the anesthetized patient.Restart of angiography device (dsa) and the operating table did not resolve the issue as the table top could be barely moved.It was estimated that there was a delay in the operation.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.Corrected b5 describe event or problem: on 7th 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 table top could not be moved during surgery, which affected the surgical procedure on the anesthetized patient.Restarting of angiography device (dsa) and the operating table did not resolve the issue as the table top could be barely moved.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 procedure, was to reoccur.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.Previous h6 health effect ¿ impact codes: surgical intervention|prolonged surgery||4632 corrected h6 health effect ¿ impact codes: no health consequences or impact|||2199.

• Brand Name: MAGNUS CARBON-FIBRE TABLE TOP,185 CM, EU
• Type of Device: TABLE, RADIOLOGIC
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: holger ullrich ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 18343764
• MDR Text Key: 330668770
• Report Number: 8010652-2023-00143
• Device Sequence Number: 1
• Product Code: KXJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 118016A1
• Device Catalogue Number: 118016A1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1