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

Model Number	116001D0
Medical Device Problem Codes	Failure to Charge (1085); Positioning Failure (1158); Failure to Run on Battery (1466)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1b event site name: (b)(6).
Event or Problem Description
On 18th march 2024, getinge became aware of an issue with one of our columns - 116001d0 - or table column, manoeuvrable.As it was stated, the table could not be operated via the ir remote nor the emergency remote at the end of critical neurological surgery on the anesthetized patient.There was no delay as the failure occurred just when the surgery was finished.The table was replaced and the hospital program continued.According to information provided by getinge service technician, the batteries were discharged and the table worked properly after connecting to the power supply.In addition, the table suffered an impact to the fairings and the frame supporting them was broken.As the result, the connection cable of one of the i/o cards was damaged and blocked the table.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely operating table not responding to remote control nor override panel leading to inability to position the table, was to reoccur.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our columns - 116001d0 - or table column, manoeuvrable.As it was stated, the table could not be operated via the ir remote nor the emergency remote at the end of critical neurological surgery on the anesthetized patient.There was no delay as the failure occurred just when the surgery was finished.The table was replaced and the hospital program continued.According to information provided by getinge service technician, the batteries were discharged and the table worked properly after connecting to the power supply.In addition, the table suffered an impact to the fairings and the frame supporting them was broken.As the result, the connection cable of one of the i/o cards was damaged and blocked the table.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely operating table not responding to remote control nor override panel leading to inability to position the table, was to reoccur.The getinge technician has assessed that ir case (component number 86015512), cable protection sheet ir-housing (component number 72061674), connecting cable i/o board (a-side) (component number 2009863) and support frame (component number 40056151) required replacement.The customer has decided to repair the operating table by their own means.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment, and thus were also directly involved with the reported incident.As the malfunction was found, it was considered that the getinge device failed to meet its specification.A review of the received customer product complaints revealed that in the past there was no serious injury to the patient or user when this particular issue occurred.Comparing the number of complained devices to the number of investigated otesus 116001 columns on the market we can conclude the failure ratio is 0,016% for the issue investigated herein.The issue investigated herein is a single and isolated case.One of the reasons why the table was inoperable was the fact that the batteries were discharged as the table worked properly after connecting to the power supply.In the instruction for use (ifu 1160.01 rev.15, page 76),the customer is advised that the product can no longer be adjusted if the batteries are discharged and the mains supply is interrupted.The customer shall connect the product for mains operation to an uninterrupted power supply (ups) or to a stationary emergency power generator.The customer is also informed (ifu 1160.01 rev.15, page 75), the override control panel works with rechargeable batteries of the independently manoeuvrable column that are discharged as long as the column is connected to the power supply.In addition, the table suffered an impact which damaged several components the collision was caused by the customer and contributed to the event occurrence.In the ifu (ifu 1160.01 rev.15, page 78), the customer is warned that when moving the independently manoeuvrable column there is a risk of collision with the environment.To prevent collisions when moving the independently manoeuvrable column, two people shall guide the or table.In summary and as a result of the performed root cause evaluation, it was concluded that based on available information the root cause of the reported issue, namely operating table not responding to remote control nor override panel leading to inability to position the table, is related to the user error.It is evident that the customer disregarded guidelines contained in the instructions for use.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 d1 brand name, d4 catalog #, d4 serial #, d4 unique identifier (udi) #, h4 device manufacture date, h6 medical device ¿ problem code and h6 component codes fields deems required.This is based on the internal evaluation.Previous d1 brand name: or table column, manoeuvrable corrected d1 brand name: otesus operating table system previous d4 catalog #: 116001d0 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: 09/01/2023 corrected h4 device manufacture date: 07/18/2023 previous h6 medical device ¿ problem code: activation, positioning or separationproblem|positioning problem|positioning failure|1158 electrical /electronic property problem|charging problem|failure to charge|1085 corrected h6 medical device ¿ problem code: activation, positioning or separationproblem|positioning problem|positioning failure|1158 electrical /electronic property problem|battery problem|failure to run on battery|1466 previous h6 component codes: electrical and magnetic|circuit board||427 electrical and magnetic|cable, electrical||423 corrected h6 component codes: electrical and magnetic|cable, electrical||423 electrical and magnetic|battery||420.
Event or Problem Description
Manufacturer's reference number (b)(4).

• Brand Name: OTESUS 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: 19017896
• Report Number: 8010652-2024-00048
• Device Sequence Number: 19838850
• Product Code: FQO
• UDI-Device Identifier: 04046768122161
• UDI-Public: (01)04046768122161(11)230718
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 04/02/2024

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
• Device Model Number: 116001D0
• Device Catalogue Number: 116001D0
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown