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

Model Number 118001A0

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).At the time of this report the investigation was 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

It was reported that the tabletop moved to trend while a patient was positioned on it.No patient harm occurred.The patient was anesthetised when the issue occurred.He was transferred to another table and the surgery was finished in another room.Since no other room was ready, the operation was finished with more than half an hour of delay.(b)(4).

Manufacturer Narrative

The affected device was investigated.This investigation revealed that a hydraulic line was torn and has caused the described malfunction.The hydraulic line was not in the position it was originally mounted in.Due to this changed position the line was exposed to higher stress compared to its original position.We assume that the hydraulic line was torn due to this incorrect loading.The hydraulic cline is connected to a cylinder.This cylinder is mounted turnable to another cylinder.If the rotation movement between the two cylinders is inhibited, the hydraulic line may be moved from its original position and be subject to higher loads.The connection between the two cylinders is lubricated.In case this lubrication is poor the described inhibition may occur.Reasons for such a poor lubrication might be wear out or a manufacturing failure.The product has been in use for more than seven years.That is why we assume a this was most likely not due to a manufacturing error.We assume a manufacturing error would have caused a defect at the hydraulic line earlier.The described issue could be caused by errors related to previously performed repair or maintenance work on the table.This work can be performed by the hospitals biomed or getinge-maquet service technicians.The getinge-maquet service technicians are provided with repair and maintenance instructions.They are trained concerning maintenance and repair work that needs to be performed.The production re the exact origin for the unsuitable position of this hydraulic line could not be determined.This is the first customer complaint we have received concerning this kind of failure (torn hydraulic line) for this product.Maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

Manufacturer reference #: (b)(4).

• 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: 8691238
• MDR Text Key: 147740425
• Report Number: 8010652-2019-00018
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 118001A0
• Device Catalogue Number: 118001A0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other