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

Model Number 1150.30B0

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2015

Event Type  malfunction  

Event Description

After completion of a procedure when the operation room table top with a patient on it was transferred onto the transporter, the user noticed a break in the central chassis of the operation room table top.No injury was reported to maquet.(b)(4).

Manufacturer Narrative

The table top has been sent to rastatt for investigation.Maquet found that the central chassis of the tabletop was broken in two locations toward the head side of the tabletop.Collision with an obstacle below the table top when adjusting the height (for example: the transporter is not moved completely under the column for the postoperative transfer) can cause this type of reported malfunction.Maquet found marks on the underside of the table top consistent with collision damage.Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: MAQUET MODULAR UNIVERSAL TABLE TOP
• 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: 4751341
• MDR Text Key: 5888905
• Report Number: 8010652-2015-00005
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1150.30B0
• Device Catalogue Number: 1150.30B0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• 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: 80