MAUDE Adverse Event Report: HOLGER ULLRICH 1150 OR-TABLE COLUMN, MOBIL; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 115002C0

Device Problems Unintended Movement (3026); Insufficient Information (3190)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

At time of this report the investigatin is still ongoing.When the investigation is complete the report will be updated and a follow up medwacht will be sumbmitted.The complete event site name is: (b)(6).

Event Description

The following was reported.A surgery was canceled, because the column could not be adjusted as intended.No injury was reported to us.Manufacturer reference#: (b)(4).

Event Description

When we received the complaint, the following was reported to us.A surgery was canceled, because the column could not be adjusted as intended.After requesting further information, we grew to know, that no surgery was canceled.No injury occurred.Manufacturer reference#: (b)(4).

Manufacturer Narrative

A getinge-maquet field service engineer (fse) has investigated the affected product.The result of this investigation was, that the the height guiding had to be readjusted.If it is misadjusted, there will be an increased play in the trend and tilt function of the table.A possible root cause for this missing adjustment is that the table was overloaded.In the instructions for use (ifu) the permissible load is provided.The user is told in the ifu to check the product prior to use and to only use a fully functional product: "warning! injury hazard! maquet products may be used only when fully functional.Check to ensure that this maquet product is fully functional and in good working order prior to use." getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: 1150 OR-TABLE COLUMN, MOBIL
• 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: 11145434
• MDR Text Key: 226074523
• Report Number: 8010652-2021-00002
• 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: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 115002C0
• Device Catalogue Number: 115002C0
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other