MAUDE Adverse Event Report: KEHLER STRASSE 31 MAQUET OR TABLE SYSTEM MAGNUS; TABLE, OPERATING-ROOM, AC-POWERED

Catalog Number 1180.13A0

Device Problem Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 05/13/2016

Event Type  malfunction  

Manufacturer Narrative

A maquet field service engineer (fse) was on-site and investigated the product in question.He learned that a member of the clinical staff had released a safety locking lever during the procedure.Due to the safety locking lever being released, the table stopped movement, as already described in the instructions for use (ifu).This reaction of the table is correct and is put in place as a safety measure/precaution.No malfunction of the product in question has occurred, as a result of this measure/precaution.The failure was caused by the user (wrong use of the device/not according the ifu).Maquet (b)(4) provides a product failure investigation, analysis, and a resolution for the device described in this report.

Event Description

According to the customer, the table top stopped positioning movement during a surgery.The customer wasn't able to get patient into the desired position and decided to cancel the surgery.(b)(4).

• Brand Name: MAQUET OR TABLE SYSTEM MAGNUS
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): KEHLER STRASSE 31; rastatt 76437 ; GM 76437
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5720325
• MDR Text Key: 48203630
• Report Number: 8010652-2016-00006
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1180.13A0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2014
• 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