MAUDE Adverse Event Report: MAQUET GMBH YUNO II MOBILE OPERATING TABLE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number	143302B0
Medical Device Problem Codes	Positioning Failure (1158); Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1: (b)(6).
Event or Problem Description
On 12th june 2024, getinge became aware of an issue with one of our mobile tables - 143302b0 - yuno 2 eu with autodrive.As it was stated, the surgeon finished the case and wanted to lower the table from the maximum height position.The table was totally unresponsive from handset and override panel and the anesthetized patient could not be lowered.There was a message of no communication or data shown on a hand control.The control unit was checked and it was confirmed that led was flashing when handset buttons were pressed.The issue resulted in a delay.Based on the evaluation provided by the technician, the malfunction of control unit was confirmed.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the operating table not responding to remote control or override panel leading to inability to position the table due to control unit malfunction, was to reoccur.
Event or Problem Description
Getinge became aware of an issue with one of our mobile tables - 143302b0 - yuno 2 eu with autodrive.As it was stated, the surgeon finished the case and wanted to lower the table from the maximum height position.The table was unresponsive from the handset and override panel and the anesthetized patient could not be lowered.There was a message of no communication or data shown on a hand control.The control unit was checked, and it was confirmed that the led was flashing when handset buttons were pressed.The issue resulted in a delay.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the operating table not responding to the remote control or override panel leading to the inability to position the table, was to reoccur.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our mobile tables - 143302b0 - yuno 2 eu with autodrive.As it was stated, the surgeon finished the case and wanted to lower the table from the maximum height position.The table was unresponsive from the handset and override panel and the anesthetized patient could not be lowered.There was a message of no communication or data shown on a hand control.The control unit was checked, and it was confirmed that the led was flashing when handset buttons were pressed.The issue resulted in a delay.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the operating table not responding to the remote control or override panel leading to the inability to position the table, was to reoccur.A review of the received customer product complaints revealed that there were no serious injuries to a user nor to a patient or operator when this particular issue occurred.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 malfunction occurred, it was considered that the getinge device failed to meet its specifications.The affected device was evaluated by a getinge technician.The 9709362 column controller unit was replaced and the device was returned to service.A review of the customer product complaint database revealed that there were no previous complaints related to this particular device.The affected part was scrapped making further analysis impossible.Therefore, it was determined that the exact cause of the described event could not be identified.In summary and as a result of the performed root cause evaluation, it was concluded that the investigated issue, namely the operating table not responding to the remote control or override panel leading to the inability to position the table, was impossible to define.We currently do not have any information that would warrant further action regarding 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) #, h4 device manufacture date deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 12th june 2024, getinge became aware of an issue with one of our mobile tables - 143302b0 - yuno 2 eu with autodrive.As it was stated, the surgeon finished the case and wanted to lower the table from the maximum height position.The table was totally unresponsive from handset and override panel and the anesthetized patient could not be lowered.There was a message of no communication or data shown on a hand control.The control unit was checked and it was confirmed that led was flashing when handset buttons were pressed.The issue resulted in a delay.Based on the evaluation provided by the technician, the malfunction of control unit was confirmed.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the operating table not responding to remote control or override panel leading to inability to position the table due to control unit malfunction, was to reoccur.Corrected b5 describe event or problem: getinge became aware of an issue with one of our mobile tables - 143302b0 - yuno 2 eu with autodrive.As it was stated, the surgeon finished the case and wanted to lower the table from the maximum height position.The table was unresponsive from the handset and override panel and the anesthetized patient could not be lowered.There was a message of no communication or data shown on a hand control.The control unit was checked, and it was confirmed that the led was flashing when handset buttons were pressed.The issue resulted in a delay.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the operating table not responding to the remote control or override panel leading to the inability to position the table, was to reoccur.Previous d1 brand name: yuno 2 eu with autodrive; corrected d1 brand name: yuno ii mobile operating table.Previous d4 catalog #: 143302b0; 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 h4 device manufacture date: 10/01/2023; corrected h4 device manufacture date: 09/08/2023.
Additional Manufacturer Narrative
The purpose of this submission is to provide an additional h6 type of investigation code.
Event or Problem Description
Manufacturer's reference number (b)(4).

• Brand Name: YUNO II MOBILE OPERATING TABLE
• 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: 19605026
• Report Number: 8010652-2024-00070
• Device Sequence Number: 12370623
• Product Code: FQO
• UDI-Device Identifier: 04046768133013
• UDI-Public: (01)04046768133013(11)230908
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 06/25/2024

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: 143302B0
• Device Catalogue Number: 143302B0
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 03/28/2025; 04/02/2025
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 04/02/2025; 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown