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

Model Number	118001B2
Medical Device Problem Codes	Computer Software Problem (1112); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
Event or Problem Description
On 17th february 2023, getinge became aware of an issue with one of our columns - 118001b2 - hybrid or table column, surface-mounted used with siemens angiography system.As it was stated, magnus hybrid system stopped working during a surgery on the anesthetized patient.According to the provided information, the surgery ended when the incident occurred and the patient was transferred to bed with difficulty.There was no injury reported, however, we decided to report the issue in abundance of caution based on potential for serious injury if the situation, namely magnus hybrid system not working during surgery which could potentially lead to delay in treatment and 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 used with siemens angiography system.As it was stated, magnus hybrid system stopped working during a surgery on the anesthetized patient.According to the provided information, the surgery has already ended when the incident occurred and the patient was transferred to bed with difficulty.The incident was initially assessed as reportable due to a delay in treatment and 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 the intermittent communication failure.The device was being used for patient treatment when the malfunction occurred.The manufacturer initiated ecr 20w285.In our evaluation the information we currently hold does not warrant any 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 unique identifier (udi)#, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain, h4 device manufacture date, h6 medical device ¿ problem code and h6 health effect ¿ impact codes fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 17th february 2023, getinge became aware of an issue with one of our columns - 118001b2 - hybrid or table column, surface-mounted used with siemens angiography system.As it was stated, magnus hybrid system stopped working during a surgery on the anesthetized patient.According to the provided information, the surgery ended when the incident occurred and the patient was transferred to bed with difficulty.There was no injury reported, however, we decided to report the issue in abundance of caution based on potential for serious injury if the situation, namely magnus hybrid system not working during surgery which could potentially lead to delay in treatment and prolonged anesthesia time, was to reoccur.Corrected b5 describe event or problem: on 17th february 2023, getinge became aware of an issue with one of our columns - 118001b2 - hybrid or table column, surface-mounted used with siemens angiography system.As it was stated, magnus hybrid system stopped working during a surgery on the anesthetized patient.According to the provided information, the surgery has already ended when the incident occurred and the patient was transferred to bed with difficulty.The incident was initially assessed as reportable due to a delay in treatment and 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#: (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: 03/01/2020 corrected h4 device manufacture date: 02/24/2020 previous h6 medical device ¿ problem code: activation, positioning or separation problem | positioning problem | 3009 corrected h6 medical device ¿ problem code: computer software problem / 1112 previous h6 health effect ¿ impact codes: insufficient information|||4648 corrected h6 health effect ¿ impact codes: surgical intervention | prolonged surgery | 4632.
Event or Problem Description
On 17th february 2023, getinge became aware of an issue with one of our columns - 118001b2 - hybrid or table column, surface-mounted used with siemens angiography system.As it was stated, magnus hybrid system stopped working during a surgery on the anesthetized patient.According to the provided information, the surgery has already ended when the incident occurred and the patient was transferred to bed with difficulty.The incident was initially assessed as reportable due to a delay in treatment and 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: 16559653
• Report Number: 8010652-2023-00020
• Device Sequence Number: 17532882
• Product Code: FQO
• UDI-Device Identifier: 04046768088351
• UDI-Public: (01)04046768088351(11)200224
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 03/16/2023

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: 02/17/2023
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown