MAUDE Adverse Event Report: KEHLER STRASSE 31 MAQUET MODULAR UNIVERSAL TABLE TOP; TABLE, OPERATING-ROOM, AC-POWERED

Catalog Number 115030F0

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2016

Event Type  malfunction  

Manufacturer Narrative

The case is still under investigation.A follow-up report will be submitted once additional information is available.Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

The customer reported that during a procedure one leg plate of the operating table came apart.The patient was not injured.(b)(4).

Manufacturer Narrative

During the investigation the described failure was confirmed.One leg plate of the table top was apart.This failure / malfunction is only possible due to serious pre-existing damage, a collision, an excessive overload, or typically someone sitting on the leg plate of the table top.The defective parts have been replaced on the table top.The table top was adjusted and the functionality was checked.All tests have been passed and the table top was released to usage.Maquet (b)(4) provides product failure investigation, analysis, and resolution for the device described in this report.

Event Description

(b)(4).

• Brand Name: MAQUET MODULAR UNIVERSAL TABLE TOP
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): KEHLER STRASSE 31; rastatt 76437 ; GM 76437
• Manufacturer (Section G): KEHLER STRASSE 31; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 5872477
• MDR Text Key: 53010095
• Report Number: 8010652-2016-00017
• 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: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 115030F0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2007
• 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