MAUDE Adverse Event Report: MAQUET SAS - ORLEANS -FRANCE PRISMALIX

Model Number PRX6000

Device Problems Corroded (1131); Flaked (1246); Device Damaged by Another Device (2915)

Patient Problem No Patient Involvement (2645)

Event Date 02/14/2014

Event Type  malfunction  

Event Description

Customer contacted maquet service reporting paint chips coming off of the large light head arm.According to the customer, there was no patient involvement.(b)(4).

Manufacturer Narrative

A maquet field service technician (fst) inspected the large light head arm on this device.The painted surfaces seemed to be properly bonded and there was no evidence of peeling paint which would be easily scraped or knocked loose.Initial observations suggested the reported chips may have resulted from impact damage.Hospital staff informed to fst this area of the light may have been hit with a large ortho table which could have caused the reported paint chips.The fst inspected he rest of the configuration and found some exposed metal at connection point which had rusted.Maquet service is presently attempting to review cleaning protocols with the hospital's infection control department to ensure their processes and solvents are not adversely affecting the finish of the lights.The st provided the hospital a quote to replace the damaged parts.Maquet medical systems usa submits this report on behalf of the device manufacturing facility.Maquet (b)(4) provides product failure investigation, analysis and resolution of the device described in this report.

• Brand Name: PRISMALIX
• Manufacturer (Section D): MAQUET SAS - ORLEANS -FRANCE
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon, orleans cedex 2 4507 4; FR 45074
• Manufacturer Contact: janice pevide ; 45 barbour pond dr; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3868726
• MDR Text Key: 15361371
• Report Number: 9710055-2014-00031
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040015
• 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: 05/07/2014,02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRX6000
• Device Catalogue Number: 567237998
• Other Device ID Number: 567216995
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/18/2014
• Event Location: Hospital
• Date Manufacturer Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2005
• 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