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

Model Number 118001A0

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

At the time of this report the investigation is still ongoing.As soon as the investigation is finished the report will be updated and a follow-up/final report will be provided to the fda.

Event Description

The following was reported.During an operation a hycraulic line broke.The patient who was on the table needed to be transferred due to this defect.The column head tilted.No injury was reported due to this issue.Manufacturer reference# (b)(4).

Event Description

Manufacturer reference# (b)(4).

Manufacturer Narrative

The defective or table column was returned and investigated.This investigation revealed the following.The unintended motion of the inclination functions results from a fissure of the hydraulic pipe near the connection to the inclination cylinder.The column head can be tilted.This is done to tilt the table top, which is connected to it.The inclination cylinder should not follow this tilt movement.At the affected column, the inclination cylinder moved and rotated when the tilt function was operated.It moved into a position in which a force was applied to the hydraulic line.Over time (creeping process) this force led to the damage and leakage at the hydraulic line, which caused the described malfunction (unintended inclination movement).At the end of 2016 a supplier was changed and tolerances were adapted.During the root cause analysis it became obvious that this change in tolerances contributes to this problem.If the screw connection between the inclination cylinder and column loosens, the cylinder will rotate.Due to this rotation, the hydraulic pipe is loaded in an unsuitable way and the described damage can occur.The tightening torque that is applied to the inclination cylinder during production is 40 nm (newton meters).This torque is too low to avoid a pretension loss.(b)(4) is performed to address this issue.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: MAGNUS TABLE COLUMN FOR BUILT-IN PLATE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 10762113
• MDR Text Key: 213875289
• Report Number: 8010652-2020-00022
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 118001A0
• Device Catalogue Number: 118001A0
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other