MAUDE Adverse Event Report: MAQUET GMBH OR TABLE COLUMN, MANOEUVRABLE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 116001D0

Device Problems Circuit Failure (1089); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2023

Event Type  malfunction  

Event Description

On 14th february 2023 getinge became aware of an issue with one of our columns ¿ 116001d0 - or table column, manoeuvrable.As it was stated, during preparation for the surgery, the patient was placed on the operating table top and before the patient was anesthetized staff noticed the table top was slightly tilted.The staff pressed button on the remote control to put the table into horizontal position.Consequently, the table became more tilted.Staff immediately stopped pressing the button.The movement of the table stopped due to contact of table top with the column.It was reported that the anesthesiologist was able to prevent the patient from falling.The surgery was completed on the another operating table.There was no injury reported, however, we decided to report the issue in abundance of caution based on the potential for serious injury if the described situation, which could lead to patient's fall, was to reoccur.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

• Brand Name: OR TABLE COLUMN, MANOEUVRABLE
• Type of Device: 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: 16493913
• MDR Text Key: 310877427
• Report Number: 8010652-2023-00016
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 116001D0
• Device Catalogue Number: 116001D0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1