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

Model Number 118001B2

Device Problem Communication or Transmission Problem (2896)

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

Event Date 06/29/2022

Event Type  malfunction  

Event Description

On 19th july, 2022 getinge became aware of an issue with one of our columns - 118001b2 - hybrid or table column, surface-mounted that was used with siemens angiography system.According to initially provided information, the siemens angiography system could not be moved and the column was resetted to resolve the issue.The incident took place at the beginning of examination of the anesthetized patient.As it was stated by equipment coordinator at the facility, there was no injury of the patient.However, the procedure was cancelled.We decided to report the issue as serious injury in case of event recurrence cannot be excluded.

Manufacturer Narrative

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

Manufacturer Narrative

Getinge became aware of an issue with one of our columns - 118001b2 - hybrid or table column, surface-mounted that was used with siemens angiography system.The siemens angiography system could not be moved, the c-arm was stuck at ceiling.The incident took place at the beginning of patient examination.There was no injury of the patient reported.As an effect of the situation occurrence the surgery was cancelled and since it did happen on the already anesthetized patient, it has been considered as a delay in treatment.We decided to report the issue based on the potential for serious injury if the situation was to reoccur.The system that took part in the described incident, has been evaluated by qualified representative from siemens who reset the column to resolve the issue.Following that evaluation, the operating table was also checked by getinge representative who could not confirm any malfunction of the column.Based on the provided information, it was one time event.The error logs provided by siemens were forwarded to the subject matter expert at the getinge manufacturing site for the root cause assessment, however the sme was unable to analyze it, stating that the data was only regarding the siemens device and did not concern the affected magnus column.No further logs could be obtained from the customer.As no technical issues could have been found on the device involved and getinge service technician was not able to duplicate the alleged situation, thus the root cause of the situation occurrence remains impossible to define.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment, thus was also directly involved with the reported incident.As the siemens representative has reset the magnus column to solve the issue, it was considered that the getinge device was not up to the specification.The situation is considered as single and isolated per a review performed as part of the investigation.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 h4 device manufacture date fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 19th july, 2022 getinge became aware of an issue with one of our columns - 118001b2 - hybrid or table column, surface-mounted that was used with siemens angiography system.According to initially provided information, the siemens angiography system could not be moved and the column was resetted to resolve the issue.The incident took place at the beginning of examination of the anesthetized patient.As it was stated by equipment coordinator at the facility, there was no injury of the patient.However, the procedure was cancelled.We decided to report the issue as serious injury in case of event recurrence cannot be excluded.Corrected b5 describe event or problem: on 19th july 2022 getinge became aware of an issue with one of our columns - 118001b2 - hybrid or table column, surface-mounted that was used with siemens angiography system.The siemens angiography system could not be moved, the c-arm was stuck at ceiling.The incident took place at the beginning of patient examination.There was no injury of the patient reported.As an effect of the situation occurrence the surgery was cancelled and since it did happen on the already anesthetized patient, it has been considered as a delay in treatment.We decided to report the issue based on the potential for serious injury if the situation was to reoccur.Previous h4 device manufacture date: 05/15/2019.Corrected h4 device manufacture date: 03/11/2019.

Event Description

On 19th july 2022 getinge became aware of an issue with one of our columns - 118001b2 - hybrid or table column, surface-mounted that was used with siemens angiography system.The siemens angiography system could not be moved, the c-arm was stuck at ceiling.The incident took place at the beginning of patient examination.There was no injury of the patient reported.As an effect of the situation occurrence the surgery was cancelled and since it did happen on the already anesthetized patient, it has been considered as a delay in treatment.We decided to report the issue based on the potential for serious injury if the situation was to reoccur.

• Brand Name: HYBRID OR TABLE COLUMN, SURFACE-MOUNTED
• Type of Device: 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: 15247421
• MDR Text Key: 305506898
• Report Number: 8010652-2022-00021
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• 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
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1