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

Model Number	118001B1
Medical Device Problem Codes	Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Event site address: (b)(6).Event site postal code: (b)(6).H3 other text : device not returned to manufacturer.
Event or Problem Description
On 4th september 2023 getinge became aware of an issue with one of our columns ¿ 118001b1 hybrid or table column, surface-mounted.As it was stated, the connection between 118001b1 hybrid or table column, surface-mounted and philips c-arm was cut off during the surgery (tavi) on the anesthetized patient.The surgery was delayed by 30 minutes.There was no injury of the patient reported, however, 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.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our columns ¿ 118001b1 hybrid or table column, surface-mounted.As it was stated, the connection between 118001b1 hybrid or table column, surface-mounted and philips c-arm was cut off during the surgery (tavi) on the anesthetized patient.The surgery was delayed by 30 minutes.The incident was initially assessed as reportable due to a delay in surgery resulting in prolonged anesthesia time.According to the subject matter expert's assessment of the error logs, the incident is traced to the known issue with the philips system related to the violation or the misuse of the interface specification by the interface partner.As the cause of the malfunction was traced to device manufactured by philips, the scenario described in the record is considered as non-reportable.It was established that the device did not fail to meet the manufacturer's specification.The device was being used for patient treatment when the issue occurred.The described communication issues were investigated within capa: 2023-011 and further investigation at philips.The appropriate actions at philips's side have been decided.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)#, e1b event site name, e1c event site address, 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 4th september 2023, getinge became aware of an issue with one of our columns ¿ 118001b1 hybrid or table column, surface-mounted.As it was stated, the connection between 118001b1 hybrid or table column, surface-mounted and philips c-arm was cut off during the surgery (tavi) on the anesthetized patient.The surgery was delayed by 30 minutes.There was no injury of the patient reported, however, 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 4th september 2023, getinge became aware of an issue with one of our columns ¿ 118001b1 hybrid or table column, surface-mounted.As it was stated, the connection between 118001b1 hybrid or table column, surface-mounted and philips c-arm was cut off during the surgery (tavi) on the anesthetized patient.The surgery was delayed by 30 minutes.The incident was initially assessed as reportable due to a delay in surgery resulting in prolonged anesthesia time.According to the subject matter expert's assessment of the error logs, the incident is traced to the known issue with the philips system related to the violation or the misuse of the interface specification by the interface partner.As the cause of the malfunction was traced to device manufactured by philips, 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#: 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 e1b event site name: (b)(6).Corrected e1b event site name: (b)(6).Previous e1c event site address: (b)(6).Corrected e1c event site address: (b)(6).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: 04/01/2020.Corrected h4 device manufacture date: 03/13/2020.Previous h6 medical device ¿ problem code: communication or transmission problem|||2896.Corrected h6 medical device ¿ problem code: adverse event without identified device or use problem|||2993.
Event or Problem Description
On 4th september 2023, getinge became aware of an issue with one of our columns ¿ 118001b1 hybrid or table column, surface-mounted.As it was stated, the connection between 118001b1 hybrid or table column, surface-mounted and philips c-arm was cut off during the surgery (tavi) on the anesthetized patient.The surgery was delayed by 30 minutes.The incident was initially assessed as reportable due to a delay in surgery resulting in prolonged anesthesia time.According to the subject matter expert's assessment of the error logs, the incident is traced to the known issue with the philips system related to the violation or the misuse of the interface specification by the interface partner.As the cause of the malfunction was traced to device manufactured by philips, 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: 17727041
• Report Number: 8010652-2023-00080
• Device Sequence Number: 20435895
• Product Code: FQO
• UDI-Device Identifier: 04046768040700
• UDI-Public: (01)04046768040700(11)200313
• 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): 09/12/2023

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: 118001B1
• Device Catalogue Number: 118001B1
• 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: 09/04/2023
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown