MAUDE Adverse Event Report: MAQUET GMBH MAGNUS TABLE COLUMN FOR BUILT-IN PLATE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 118001A0

Device Problems Crack (1135); Unintended System Motion (1430)

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

Event Date 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.E1b event site name: innklinikum altötting h3 other text : device not returned to manufacturer.

Event Description

On 16th october 2023 getinge became aware of an issue with one of our columns - 118001a0 - magnus table column for built-in plate.As it was stated, the hydraulic cylinder used for movement to the trendelenburg/reverse-trendelenburg position came loose during tilt movement which damaged the hydraulic line to such an extent that a crack was formed resulting in a hydraulic oil leak.This led to an uncontrollable movement of the table top from trendelenburg position in the other direction.The motion of the table was counteracted by the staff and the table was moved into zero position.According to provided information, at the time of incident laparoscopic procedure was completed and the patient was still anesthetized and secured with the straps.It was confirmed the patient did not suffer any harm due to the issue.We decided to report the issue based on the potential for serious injury if the situation, namely the uncontrollable unintended movement of the table due to the hydraulic line malfunction during a procedure, was to reoccur.

• Brand Name: MAGNUS TABLE COLUMN FOR BUILT-IN PLATE
• 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: 18021646
• MDR Text Key: 326736506
• Report Number: 8010652-2023-00117
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 118001A0
• Device Catalogue Number: 118001A0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1