MAUDE Adverse Event Report: MAQUET S.A.S - ORLEANS - FRANCE POWERLED; FSY

Model Number PWD700SFR

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer contacted maquet and reported that the bearing between the spring arm and the fork has failed.It has excessive free-play, feels like it is grinding and a black powdery debris is falling out of the gap when it moves.There was no patient in the room and no injuries were reported.Factory reference number: (b)(4).

Manufacturer Narrative

Maquet determined that the cause of the failure is related to a lack of grease at the junction between the fork and the spring arm, leading to a grinding during manipulation of the lighthead.In the power lead operating manual, maquet suggests to customers that the light be removed and the sleeve be lubricated every year by a certified technician.Maquet is not responsible for maintenance of this device.The customer contacted maquet service to determine the correct p/n for the repair.The customer is intending to order the part and do the repair.

• Brand Name: POWERLED
• Type of Device: FSY
• Manufacturer (Section D): MAQUET S.A.S - ORLEANS - FRANCE
• Manufacturer Contact: marie cabel ; parc de limere; avenue de la pomme de pin; ardon, orleans cedex 2 45074 ; FR 45074 ; 37013004
• MDR Report Key: 4607781
• MDR Text Key: 21832522
• Report Number: 9710055-2015-00023
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PWD700SFR
• Other Device ID Number: 568301799
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1