MAUDE Adverse Event Report: MAQUET GMBH MODULAR UNIVERSAL TABLE TOP; TABLE, OPERATING-ROOM, AC-POWERED

Model Number	115030D0
Medical Device Problem Codes	Crack (1135); Fracture (1260); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 13th february 2024, getinge became aware of an issue with one of our table tops ¿ 115030d0 - modular universal table top.As it was stated, the customer drove onto an equipment trolley breaking central housing while the patient was lying on the operating table.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely broken central housing which could cause unintended movement of the table top and create a risk of patient's fall, was to reoccur.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1b event site name: (b)(6).H3 other text : device not returned to manufacturer.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our tabletops ¿ 115030d0 - modular universal tabletop.As it was stated, the customer drove onto an equipment trolley breaking central housing while the patient was lying on the operating table.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely broken central housing which could cause unintended movement of the tabletop and create a risk of patient's fall, was to reoccur.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 of the center body housing was found, it was considered that the getinge device failed to meet its specifications.A review of the received customer product complaints revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.Comparing the number of devices involved in the adverse event to the number of sold devices worldwide, we can assume that the failure ratio of the issue investigated herein is (b)(4).The affected getinge device has been evaluated by the technician.The evaluation revealed the malfunction of the center body housing.The technician provided information that due to the age of the tabletop, the device will not be repaired but will be removed from use and scrapped.The customer has a maintenance agreement with getinge.In the maintenance manual for 115030d0 - modular universal tabletop (sp11 5010 de10, page 8) it is stated that during the maintenance all 4 screws at the guide blocks should be checked if are tightened correctly and the surface of the connection piece between the guide block and the shift drive unit should be checked for evidence of (micro-) cracks.The technician provided information that no malfunctions with the center body housing were found during the last maintenance.Based on the information provided by the technician, the issue investigated herein was caused by a user error due to collision with other equipment at the customer site.In the user manual (ifu 1150.30 rev.18, page 21, see also page 21 from ¿attachment 2 - ifu 1150.30 rev.18¿) the user is warned that when the or table, the transporter, the table top, or a piece of accessories are moved or adjusted as well as during the take-over procedure of the table top, collisions with the patient, with the involved products, or downward positioned parts may occur.During the movement, the user should always watch the o.R.Table, the transporter, the tabletop, and the accessories to avoid collisions.In summary and as a result of the root cause evaluation, it can be concluded that the most possible root cause of the reported issue, namely defective central housing which could cause the unintended movement of the tabletop and create a risk of the patient falling, is most probably user error.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 full unique identifier (udi) # information is not available since the device was manufactured before 09/24/2022.The correction of d4 catalog #, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain, h4 device manufacture date fields deems required.This is based on the internal evaluation.Previous d4 catalog #: 115030d0.Corrected d4 catalog #: n/a.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: 10/01/2008.Corrected h4 device manufacture date: 07/09/2008.Previous h6 medical device ¿ problem code: material integrity problem|break|fracture|1260.Use of device problem|||1670.Corrected h6 medical device ¿ problem code: material integrity problem|crack||1135.Use of device problem|||1670.

• Brand Name: MODULAR UNIVERSAL TABLE TOP
• 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: 18775774
• Report Number: 8010652-2024-00026
• Device Sequence Number: 6233367
• Product Code: FQO
• UDI-Device Identifier: 04046768003354
• UDI-Public: (01)04046768003354
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 02/26/2024

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: 115030D0
• Device Catalogue Number: 115030D0
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown