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

Model Number PWD700+SFHDRK3

Device Problems Material Erosion (1214); Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2014

Event Type  malfunction  

Event Description

Customer reported to maquet sas that some black deposits were coming from the junction between the fork and the spring arm and fell onto the sterile field.No pt injury was reported to maquet.Factory reference number (b)(4).

Manufacturer Narrative

A maquet tech evaluated the junction between the fork and the spring arm and found signs of oxidation on the axis of the fork.The tech also noticed that this axis was dried (absence of grease).Maquet determined that the absence of grease has caused oxidation between the fork and the spring arm generating friction and fall of particles during lighthead positionings.In the power led operating manual, maquet requests that the final customer have the light removed and the sleeves lubricated every year by a certified tech.Maquet is not responsible for maintenance in this hosp.The tech replaced the fork, added grease and returned the device to service.

• Brand Name: POWERLED
• Manufacturer (Section D): MAQUET S.A.S.; orleans cedex 2 ; 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: 4349537
• MDR Text Key: 5171973
• Report Number: 9710055-2014-00101
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K070442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PWD700+SFHDRK3
• Device Catalogue Number: 568433710C
• Other Device ID Number: 568370939
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1