MAUDE Adverse Event Report: MAQUET GMBH AND CO. KG MAQUET, UNIVERSAL TABLE TOP; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 1150.20D0

Device Problems Improper or Incorrect Procedure or Method (2017); Maintenance Does Not Comply To Manufacturers Recommendations (2974); Material Deformation (2976)

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

Event Date 08/01/2014

Event Type  malfunction  

Event Description

Prior to surgery, with the surgical table configured for use in the "beach chair" position, the hospital staff installed a carbon fiber back plate on to the table.After being attached, the back plate dropped down into the horizontal position.No injury reported to maquet.The surgery was completed successfully.(b)(4).

Manufacturer Narrative

On (b)(6) 2014 the hospital ordered parts to complete the required repair.The repair was completed by a 3rd party company.No additional info about the repair or the incident was provided to maquet.The back plate is mobilized on the table top by means of a form closure clamp.To adjust the back plate, an operator has to press a safety push-button, open the eccentric levers on each side of the tabletop, adjust the position of the back plate and then retighten the eccentric lever to secure the unit in place.The product is designed so that if one of the eccentric mechanisms is damaged or unsecured the other one should sufficiently support the pt.However, if these clamps are not properly secured, the proper interlocking of the tooth locking mechanism may be impeded, resting in excessive wear of the teeth and if left unresolved, the potential for slippage of the tooth lock washer as reported.Because the wear down of the components observed is a gradual process, the customer could have prevented this event with proper maintenance and inspection.Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: MAQUET, UNIVERSAL TABLE TOP
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MAQUET GMBH AND CO. KG; kehler strasse 31; rastatt 7643 7; GM 76437
• Manufacturer (Section G): MAQUET GMBH
• Manufacturer Contact: janice pevide ; 45 barbour pond dr.; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 4102571
• MDR Text Key: 4756164
• Report Number: 8010652-2014-00017
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: NA
• 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: 08/27/2014,08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1150.20D0
• Device Catalogue Number: 1150.20D0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/25/2014
• Device Age: 10 YR
• Event Location: Hospital
• Date Manufacturer Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2004
• 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