MAUDE Adverse Event Report: MAQUET GMBH, MAQUET OR TABLE SYSTME MAGNUS; TABLE, OPERATING-ROOM, AC -POWERED

Model Number 1180.10A0

Device Problems Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2015

Event Type  malfunction  

Event Description

During the postoperative table top transfer from the column onto the transporter, the reverse trendelenburg movement did not work and an error message was shown on the display of the hand control.This malfunction caused a delay in transferring.No injury reported to maquet.Manufacturer reference #(b)(4).

Manufacturer Narrative

After the event a maquet field service technician (fst) was on site to investigate, the affected operation room table top.He found one defective electric drive.As a result the motor driven functions of the basic table top failed to move.However, in such a case all movements of the column and of the joint modules remain available.Also the table top transfer from the column onto the transporter can still be carried out.The operation room table system magnus is equipped with an emergency operation mode to obtain the functionality of the operation room table system as much as possible.The emergency operating mode is described in the instructions for use (b)(4).It is an isolated case.We are not aware of any similar incident.Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: MAQUET OR TABLE SYSTME MAGNUS
• Type of Device: TABLE, OPERATING-ROOM, AC -POWERED
• Manufacturer (Section D): MAQUET GMBH,; kehler strasse 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: bernd rakow ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321370
• MDR Report Key: 4524221
• MDR Text Key: 5539501
• Report Number: 8010652-2015-00001
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1180.10A0
• Device Catalogue Number: 1180.10A0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Weight: 82