MAUDE Adverse Event Report: HOLGER ULLRICH MAGNUS TABLE COLUMN, MOBILE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 118001C0

Device Problems Circuit Failure (1089); Insufficient Information (3190)

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

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

At the time of this report the investigation is still ongoing.When the investigation is complete the report will be updated and a follow up medwacht will be submitted.(b)(4).

Event Description

The following was reported.While a patient was on the table and under anesthetics, a malfunction of the table occurred.The patient was transferred and a delay of approximately 90 minutes occurred.No injury occurred.Manufacturer reference # (b)(4).

Event Description

Manufacturer reference# (b)(4).

Manufacturer Narrative

A getinge-maquet field service engineer has investigated the defective table.He has found that three electronic parts were defective.Due to the error pattern and the position of these parts in the or table, we assume they were damaged due to inappropriate cleaning.In the instructions for use (ifu) it is described how the or table should be cleaned.The user is warned in the ifu concerning risks related to inappropriate cleaning.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: MAGNUS TABLE COLUMN, MOBILE
• 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: 11768106
• MDR Text Key: 250472900
• Report Number: 8010652-2021-00019
• 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: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 118001C0
• Device Catalogue Number: 118001C0
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/28/2021
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Outcome(s): Other