MAUDE Adverse Event Report: MAQUET S.A.S PRISMATIC

Model Number PRC

Device Problems Degraded (1153); Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 07/03/2015

Event Type  malfunction  

Event Description

The customer reported that the light has paint chipping off of the spring arm and main arm due to impact with the downtube and other main arms.The hospital has been experiencing some paint chips falling onto or floor and into the sterile field during certain procedures.No injuries were reported.(b)(4).Maquet is aware of 6 similar events involving 6 separate devices.These 6 events are being reported in the mdr's #9710055-2015-00060 through 9710055-2015-00065.

Manufacturer Narrative

A maquet territory manager visited the facility, and met with the customer.They determined that this event is due to the age of the light (20+ years old) and the arms constantly colliding against one another for many years.The customer has covered areas of the light where the chipping is at its worst.The prismatic series yearly preventive maintenance program includes a verification of the "painting condition, especially in the event of shocks".

• Brand Name: PRISMATIC
• Manufacturer (Section D): MAQUET S.A.S; orleans ; FR
• Manufacturer Contact: marie-francoise cabel ; parc de limere; avenue de la pomme de pin; ardon, orleans cedex 2 45074 ; FR 45074 ; 37013004
• MDR Report Key: 4961903
• MDR Text Key: 17594286
• Report Number: 9710055-2015-00063
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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