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

Model Number 1180.01A0

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Unintended Movement (3026)

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

Event Date 04/21/2015

Event Type  malfunction  

Event Description

According to the customer, the operating room table started moving into reverse-trendelenburg position with the patient on the table.The patient nearly slid off the operating room table.No injury reported to maquet.(b)(4).

Manufacturer Narrative

A maquet field service technician (fst) visited the hospital and found a hydraulic leakage on the connection of the hydraulic cylinder for trendelenburg/reverse trendelenburg movement.Such a leakage can cause an unintended movement.Due to the fact that the movement is slow a serious injury is unlikely but it cannot be excluded.Maquet (b)(4)provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: MAQUET OR TABLE SYSTEM 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: 4787301
• MDR Text Key: 22157682
• Report Number: 8010652-2015-00009
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1180.01A0
• Device Catalogue Number: 1180.01A0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2009
• 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