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

Model Number	118001B2
Medical Device Problem Codes	Failure to Sense (1559); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
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 8th december 2023 getinge became aware of an issue with one of our columns - 118001b2 - hybrid or table column, surface-mounted.As it was stated, communication with imagining device was interrupted and the operating table stopped moving during surgery on anesthetized patient.The issue led to a delay of approximately 10 minutes due to restart of the angiography device.The staff was able to complete the procedure.Following the service visit on site, the sensor was found to be defective.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.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our columns - 118001b2 - hybrid or table column, surface-mounted.As it was stated, communication with imagining device was interrupted and the operating table stopped moving during surgery on anesthetized patient.The issue led to a delay of approximately 10 minutes due to restart of the angiography device.The staff was able to complete the procedure.Following the service visit on site, the height and trend sensors were found to be defective.The incident was initially assessed as reportable due to a delay in surgery resulting in prolonged anesthesia time.Recently, the incident has been reevaluated as according to the medical expert's assessment, the procedural delay did not have any major clinical relevance in this situation.The scenario described in the record is considered as non-reportable.It was established that the device failed to meet the manufacturer's specification due to malfunction of the sensors.The device was being used for patient treatment when the malfunction occurred.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, d1 brand name, d4 catalog #, d4 serial #, d4 unique identifier (udi) #, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code ¿ explain, h4 device manufacture date and h6 medical device ¿ problem code fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 8th december 2023 getinge became aware of an issue with one of our columns - 118001b2 - hybrid or table column, surface-mounted.As it was stated, communication with imagining device was interrupted and the operating table stopped moving during surgery on anesthetized patient.The issue led to a delay of approximately 10 minutes due to restart of the angiography device.The staff was able to complete the procedure.Following the service visit on site, the sensor was found to be defective.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 8th december 2023 getinge became aware of an issue with one of our columns - 118001b2 - hybrid or table column, surface-mounted.As it was stated, communication with imagining device was interrupted and the operating table stopped moving during surgery on anesthetized patient.The issue led to a delay of approximately 10 minutes due to restart of the angiography device.The staff was able to complete the procedure.Following the service visit on site, the height and trend sensors were found to be defective.The incident was initially assessed as reportable due to a delay in surgery resulting in prolonged anesthesia time.Recently, the incident has been reevaluated as according to the medical expert's assessment, the procedural delay did not have any major clinical relevance in this situation.The scenario described in the record is considered as non-reportable.Previous d1 brand name: hybrid or table column, surface-mounted corrected d1 brand name: magnus operating table system previous d4 catalog #: 118001b2 corrected d4 catalog #: n/a previous d4 serial #: 305 corrected d4 serial #: 00305 previous d4 unique identifier (udi) #: n/a corrected d4 unique identifier (udi) #: (01)04046768088351 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: 02/01/2019 corrected h4 device manufacture date: 12/06/2018 previous h6 medical device ¿ problem code: electrical /electronic property problem|device sensing problem||2917 corrected h6 medical device ¿ problem code: electrical /electronic property problem|device sensing problem|failure to sense|1559.
Event or Problem Description
On 8th december 2023 getinge became aware of an issue with one of our columns - 118001b2 - hybrid or table column, surface-mounted.As it was stated, communication with imagining device was interrupted and the operating table stopped moving during surgery on anesthetized patient.The issue led to a delay of approximately 10 minutes due to restart of the angiography device.The staff was able to complete the procedure.Following the service visit on site, the height and trend sensors were found to be defective.The incident was initially assessed as reportable due to a delay in surgery resulting in prolonged anesthesia time.Recently, the incident has been reevaluated as according to the medical expert's assessment, the procedural delay did not have any major clinical relevance in this situation.The scenario described in the record is considered as non-reportable.

• 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: 18371174
• Report Number: 8010652-2023-00148
• Device Sequence Number: 7767095
• Product Code: FQO
• UDI-Device Identifier: 04046768088351
• UDI-Public: (01)04046768088351
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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: 118001B2
• Device Catalogue Number: 118001B2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown