MAUDE Adverse Event Report: MAQUET GMBH MAGNUS OPERATING TABLE SYSTEM; TABLE, OPERATING-ROOM, AC-POWERED

Model Number	118001D0
Medical Device Problem Codes	Positioning Failure (1158); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
Event or Problem Description
On 18th august 2023 getinge became aware of an issue with one of our columns ¿ 118001d0 magnus or-table column, independently manoeuvrable.As it was stated, at the beginning of billary surgery after gas filling had been done, the table did not move into the indicated position.The error 159/7 (general error column) was displayed on the remote control.Based on the provided information, the battery was depleted despite the fact that the power cord of the table was connected.According to the customer allegation, there were no acoustic signals indicating the battery charge is running out.The procedure was completed on the affected table.The patient was not endangered, however, the issue made the operation considerably more difficult leading to a delay in a surgery on the anesthetized patient.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.
Event or Problem Description
On 18th august 2023, getinge became aware of an issue with one of our columns ¿ 118001d0 magnus or-table column, independently manoeuvrable.As it was stated, at the beginning of biliary surgery after gas filling had been done, the table did not move into the indicated position.The error 159/7 (general error column) was displayed on the remote control.Based on the provided information, the battery was depleted despite the fact that the power cord of the table was connected.According to the customer's allegation, there were no acoustic signals indicating the battery charge was running out.The procedure was completed on the affected table.The patient was not endangered, however, the issue made the operation considerably more difficult leading to a delay in surgery on the anesthetized patient.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 due to a battery issue, leading to the inability to position the patient as required.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our columns ¿ 118001d0 magnus or-table column, independently manoeuvrable.As it was stated, at the beginning of biliary surgery after gas filling had been done, the table did not move into the indicated position.The error 159/7 (general error column) was displayed on the remote control.Based on the provided information, the battery was depleted despite the fact that the power cord of the table was connected.According to the customer's allegation, there were no acoustic signals indicating the battery charge was running out.The procedure was completed on the affected table.The patient was not endangered, however, the issue made the operation considerably more difficult leading to a delay in surgery on the anesthetized patient.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 due to a battery issue, leading to the inability to position the patient as required.According to information provided by ssu, the hospital's maintenance staff identified a battery issue ¿ they were depleted even though the power cord of the table was connected.After the table¿s pillar batteries were replaced the device was returned to usage.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 batteries¿ 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 there were no injuries to a user nor to a patient or operator when this particular incident occurred.The affected devices were manufactured in october 2010 and had been in use for almost 13 years at the time of the event.A review of the customer product complaints database revealed no previous complaints related to the reported issues for the device.According to the risk management plan (risk management plan _ system-saeule cepg.0126, page 3, see also page 3 in ¿attachment 4 - risk management plan _ system-saeule cepg.0126¿), the expected service life of the device is 10 years.The device's age likely contributed to the issue.The table¿s pillar batteries are considered consumable items with a typical lifespan of 2 years.As stated in the service manual 1180.01 system ("attachment 2 - tr 118001d0 en 07¿, page 99), the useful life of the rechargeable batteries varies depending on their application.To ensure continued use of the product, it is recommended to check the batteries every 2 years and replace them if necessary.As stated in the ifu ("attachment 3 - ifu 1180.01 en 34¿, page 86), the rechargeable batteries in the independently maneuverable/mobile column must be inspected once a year and replaced, if necessary, by an authorized service technician.According to information provided by ssu, the customer does not have a maintenance contract with getinge¿the hospital staff handles maintenance tasks themselves.The automated maintenance system previously indicated the upcoming need for the table's annual maintenance, which included battery replacement for all maquet magnus tables.However, we cannot confirm that the hospital's maintenance staff replaced the batteries promptly, which may suggest the issue was related to user error and non-compliance with the instructions for use.According to the subject matter expert opinion, it appears that the batteries were not maintained or replaced within the correct time frame.Notably, the table was almost 13 years old when the complaint was created, indicating that the equipment was beyond its recommended operational lifespan for certain components.He advised checking the age of the defective battery, which would provide a clearer understanding of whether the battery exceeded its expected lifecycle.The wearing of components, such as batteries, is expected over time, especially in older equipment.Failure to follow the instructions for use (ifu) or the service manual, which specifies regular battery maintenance or replacement intervals, contributed to the failure.On the other hand, despite our best efforts, we were not able to establish the age of the affected batteries.In summary and as a result of the performed root cause evaluation, it can be concluded that the most possible root cause of the reported issue, was caused by user error and non-compliance with the user manual.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 correction of b5 describe event or problem, d1 brand name, d4 catalog #, d4 unique identifier (udi) #, h3c if other provide code ¿ explain, h4 device manufacture date fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 18th august 2023 getinge became aware of an issue with one of our columns ¿ 118001d0 magnus or-table column, independently manoeuvrable.As it was stated, at the beginning of billary surgery after gas filling had been done, the table did not move into the indicated position.The error 159/7 (general error column) was displayed on the remote control.Based on the provided information, the battery was depleted despite the fact that the power cord of the table was connected.According to the customer allegation, there were no acoustic signals indicating the battery charge is running out.The procedure was completed on the affected table.The patient was not endangered, however, the issue made the operation considerably more difficult leading to a delay in a surgery on the anesthetized patient.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 18th august 2023, getinge became aware of an issue with one of our columns ¿ 118001d0 magnus or-table column, independently manoeuvrable.As it was stated, at the beginning of biliary surgery after gas filling had been done, the table did not move into the indicated position.The error 159/7 (general error column) was displayed on the remote control.Based on the provided information, the battery was depleted despite the fact that the power cord of the table was connected.According to the customer's allegation, there were no acoustic signals indicating the battery charge was running out.The procedure was completed on the affected table.The patient was not endangered, however, the issue made the operation considerably more difficult leading to a delay in surgery on the anesthetized patient.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 due to a battery issue, leading to the inability to position the patient as required.Previous d1 brand name: magnus or-table column, independently manoeuvrable corrected d1 brand name: magnus operating table system previous d4 catalog #: 118001d0 corrected d4 catalog #: n/a previous d4 unique identifier (udi) #: n/a corrected d4 unique identifier (udi) #: (b)(4).Previous d9 device available for evaluation: yes corrected d9 device available for evaluation: no previous h3c if other provide code - explain: device not returned to manufacturer corrected h3c if other provide code - explain: 3rd party service/customer inspection previous h4 device manufacture date: 10/01/2010.Corrected h4 device manufacture date: 10/18/2010.

• Brand Name: MAGNUS OPERATING TABLE SYSTEM
• Common Device Name: TABLE, OPERATING-ROOM, AC-POWERED
• 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: 17661929
• Report Number: 8010652-2023-00078
• Device Sequence Number: 17923107
• Product Code: FQO
• UDI-Device Identifier: 04046768031579
• UDI-Public: (01)04046768031579
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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: 118001D0
• Device Catalogue Number: 118001D0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown