MAUDE Adverse Event Report: MAQUET GMBH MAGNUS CARBON FIBRE TABLE TOP; TABLE, RADIOLOGIC

Model Number	118016A5
Medical Device Problem Codes	Communication or Transmission Problem (2896); Device Sensing Problem (2917); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1 event site name: shibata medical science co.Ltd.E1h event site postal code: (b)(6).H3 other text : device not returned to manufacturer.
Event or Problem Description
On (b)(6) 2023 getinge became aware of an issue with one of our columns ¿ 118001b1 - hybrid or table column, surface-mounted.As it was stated, the communication issues occurred between the hybrid or table column and philips angiography device during imagining.The table stopped moving towards the head side.According to the provided information, following the event, the angiography device was restarted and the procedure was successfully performed without interlocking with the getinge remote control.The issue led to a delay of approximately 5 minutes.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely a delay in surgery resulting in prolonged anesthesia time, was to reoccur.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our table tops 118016a5 - carbon fibre top for stationary column used with 118001b1 - hybrid or table column, surface-mounted.As it was stated, the communication issues occurred between the hybrid or table column and philips angiography device during imagining.The table stopped moving towards the head side.According to the provided information, following the event, the angiography device was restarted and the procedure was successfully performed without interlocking with the getinge remote control.The issue led to a delay of approximately 5 minutes.The issue was resolved by the replacement of table top's longitudinal drive and potentiometer.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.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 b3 date of event, b5 describe event or problem, d1 brand name, d2 common device name, d4 version or model #, 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 b3 date of event: 07/20/2023.Corrected b3 date of event: 07/19/2023.Previous b5 describe event or problem: on 20th july 2023 getinge became aware of an issue with one of our columns ¿ 118001b1 - hybrid or table column, surface-mounted.As it was stated, the communication issues occurred between the hybrid or table column and philips angiography device during imagining.The table stopped moving towards the head side.According to the provided information, following the event, the angiography device was restarted and the procedure was successfully performed without interlocking with the getinge remote control.The issue led to a delay of approximately 5 minutes.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely a delay in surgery resulting in prolonged anesthesia time, was to reoccur.Corrected b5 describe event or problem: on 20th july 2023 getinge became aware of an issue with one of our table tops 118016a5 - carbon fibre top for stationary column used with 118001b1 - hybrid or table column, surface-mounted.As it was stated, the communication issues occurred between the hybrid or table column and philips angiography device during imagining.The table stopped moving towards the head side.According to the provided information, following the event, the angiography device was restarted and the procedure was successfully performed without interlocking with the getinge remote control.The issue led to a delay of approximately 5 minutes.The issue was resolved by the replacement of table top's longitudinal drive and potentiometer.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 carbon fibre table top.Previous d2 common device name: fqo table, operating-room, ac-powered.Corrected d2 common device name: kxj table, radiologic.Previous d4 version or model #: 118001b1.Corrected d4 version or model #: 118016a5.Previous d4 catalog #: 118001b1.Corrected d4 catalog #: n/a.Previous d4 serial #: (b)(6).Corrected d4 serial #: (b)(6).Previous d4 unique identifier (udi) #: n/a.Corrected d4 unique identifier (udi) #: (b)(4).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: 11/22/2018.Previous h6 medical device ¿ problem code: communication or transmission problem|||2896.Electrical /electronic property problem|device sensing problem||2917.Corrected h6 medical device ¿ problem code: activation, positioning or separationproblem|positioning problem||3009.Electrical /electronic property problem|device sensing problem||2917.
Event or Problem Description
On 20th july 2023 getinge became aware of an issue with one of our table tops 118016a5 - carbon fibre top for stationary column used with 118001b1 - hybrid or table column, surface-mounted.As it was stated, the communication issues occurred between the hybrid or table column and philips angiography device during imagining.The table stopped moving towards the head side.According to the provided information, following the event, the angiography device was restarted and the procedure was successfully performed without interlocking with the getinge remote control.The issue led to a delay of approximately 5 minutes.The issue was resolved by the replacement of table top's longitudinal drive and potentiometer.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 CARBON FIBRE TABLE TOP
• Common Device Name: 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: 17447237
• Report Number: 8010652-2023-00072
• Device Sequence Number: 7383365
• Product Code: KXJ
• UDI-Device Identifier: 04046768040779
• UDI-Public: (01)04046768040779(11)181122
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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
• Operator of Device: Health Professional
• Device Model Number: 118016A5
• Device Catalogue Number: 118001B1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 118001B1 - MAGNUS OPERATING TABLE SYSTEM.
• Patient Sex: Unknown