MAUDE Adverse Event Report: MAQUET GMBH HYBRID OR TABLE COLUMN SURFACE-MOUNTED; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 118001B1

Device Problems Installation-Related Problem (2965); Insufficient Information (3190); Intermittent Communication Failure (4038)

Patient Problem Insufficient Information (4580)

Event Date 09/23/2021

Event Type  malfunction  

Event Description

The following was reported to us.During the surgery (aortic bifurcation prosthesis deployment), communication issues between 118001b1 hybrid or table column surface-mounted and philips angiography system occured up to 3 times.Each time the restart of the devices was required.The procedure was terminated after completion of first phase due to the issue.The patient requires second surgery to complete the planned procedure.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Manufacturer Narrative

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 d3 manufacturer and b5 describe event or problem fields deems required.This is based on the additional information that has been received and the internal evaluation.Previous d3 manufacturer holger ullrich; corrected d3 manufacturer maquet gmbh.Previous b5 describe event or problem: the following was reported to us.During the surgery (aortic bifurcation prosthesis deployment), communication issues between 118001b1 hybrid or table column surface-mounted and philips angiography system occured up to 3 times.Each time the restart of the devices was required.The procedure was terminated after completion of first phase due to the issue.The patient requires second surgery to complete the planned procedure.Corrected b5 describe event or problem: on 9th may, 2022 getinge became aware of an issue with one of our columns: 118001b1 hybrid or table column surface-mounted.The following was reported to us.During the surgery (aortic bifurcation prosthesis deployment), communication issues between 118001b1 hybrid or table column surface-mounted and philips angiography system occured up to 3 times.Each time the restart of the devices was required.The procedure was terminated after completion of first phase due to the issue.The patient requires second surgery to complete the planned procedure.

Event Description

On 9th may, 2022 getinge became aware of an issue with one of our columns: 118001b1 hybrid or table column surface-mounted.The following was reported to us.During the surgery (aortic bifurcation prosthesis deployment), communication issues between 118001b1 hybrid or table column surface-mounted and philips angiography system occured up to 3 times.Each time the restart of the devices was required.The procedure was terminated after completion of first phase due to the issue.The patient requires second surgery to complete the planned procedure.

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of our columns ¿ 118001b1 hybrid or table column surface-mounted.The following was reported to us: during the surgery (aortic bifurcation prosthesis deployment), communication issues between 118001b1 hybrid or table column surface-mounted and philips angiography system (azurion flexarm) occurred up to 3 times.Each time the restart of the devices was required.The procedure was terminated after the completion of the first phase due to the interrupted work of the system.The patient required second surgery to complete the planned procedure.We decided to report the issue as the situation led to disruption and medically unnecessary expansion of the procedure when the patient was already anesthetized and created a reoperation need.

Manufacturer Narrative

Getinge became aware of an issue with one of our columns ¿ 118001b1 hybrid or table column surface-mounted.During the surgery (aortic bifurcation prosthesis deployment), communication issues between the 118001b1 hybrid or table column surface-mounted and philips angiography system (azurion flexarm) occurred up to 3 times.Each time the restart of the devices was required.The procedure was terminated after the completion of the first phase due to the issue.The patient required a second surgery to complete the planned procedure.We decided to report the issue as the situation led to disruption and medically unnecessary expansion of the procedure when the patient was already anesthetized and created a reoperation need.The affected hybrid system was evaluated by the getinge and philips technicians with the coordination of the technical support department at maquet gmbh.The information provided by the philips technician shows that the communication issues between the table column and philips angiography system (azurion flexarm) occurred since the installation of the hybrid system.The issue occurred when the customer had the angiography device positioned close to the table base, the nurses first noticed a warning message to re-apply the table brake and afterward the motorized movements were no longer possible.Analysis of the log files from the philips system performed by the manufacturer of this device showed many collision warnings before the table movements were stopped.Further analysis showed that the possible cause of the communication issue between those devices is that something interrupts the process.Due to many of the communication issues raised by the customer, the getinge and philips technicians performed a few interventions to solve the problem.Some of the components (height and trend potentiometers, column control unit, hybrid or interface) were replaced but it did not solve the problem.The wiring between the table column and the angiography system was checked.It turned out that the ethernet and data wires were very close to the current-carrying cables and this caused interference and disrupted communication between the devices.The responsibility for the proper placement of all cables is assigned to the person installing the device at the customer site and all relevant installation steps are described in the installation manual (tm 118001b1 en 07).With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment, and thus was also directly involved with the reported incident.As the wrongly-routed ethernet and data cables were found, it was considered that the getinge device was not up to specification.Based on all available information it can be concluded that all issues related to the wrong or lack of communication between the table column and the philips angiography system were caused by the inappropriate performed installation of the table column.The person responsible for the proper placement of all cables is a getinge technician.Therefore, the reported issue was caused by a service technician error.The affected customer received a new column.There were no similar complaints found related to this issue failure pattern as described in this event, therefore it appears to be isolated to this single occurrence when considering this particular device range.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 field deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on (b)(6) 2022 getinge became aware of an issue with one of our columns ¿ 118001b1 hybrid or table column surface-mounted.The following was reported to us.During the surgery (aortic bifurcation prosthesis deployment), communication issues between 118001b1 hybrid or table column surface-mounted and philips angiography system occured up to 3 times.Each time the restart of the devices was required.The procedure was terminated after completion of first phase due to the issue.The patient requires second surgery to complete the planned procedure.Corrected b5 describe event or problem: on (b)(6) 2022 getinge became aware of an issue with one of our columns ¿ 118001b1 hybrid or table column surface-mounted.The following was reported to us: during the surgery (aortic bifurcation prosthesis deployment), communication issues between 118001b1 hybrid or table column surface-mounted and philips angiography system (azurion flexarm) occurred up to 3 times.Each time the restart of the devices was required.The procedure was terminated after the completion of the first phase due to the interrupted work of the system.The patient required second surgery to complete the planned procedure.We decided to report the issue as the situation led to disruption and medically unnecessary expansion of the procedure when the patient was already anesthetized and created a reoperation need.

• Brand Name: HYBRID OR TABLE COLUMN SURFACE-MOUNTED
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer Contact: holger ullrich ; kehler strasse 31; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 14367179
• MDR Text Key: 300035340
• Report Number: 8010652-2022-00005
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 118001B1
• Device Catalogue Number: 118001B1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose