MAUDE Adverse Event Report: MAQUET SAS HLX 3000; LIGHT, SURGICAL

Model Number H5H3H3

Device Problems Corroded (1131); Flaked (1246)

Patient Problem No Patient Involvement (2645)

Event Date 03/06/2015

Event Type  malfunction  

Event Description

Customer informed maquet that the surgical light was rusted and paint was missing on some parts of the light.No injuries were reported.Factory reference number: (b)(4).

Manufacturer Narrative

Note: the hlx series light system is not marketed in the us.This report has been made due to a similarity with devices marketed by maquet in the us.A maquet service technician inspected the device and found that most parts of the system (suspension, lighthead) were rusted.The customer informed the technician that fumigation is used to disinfect the product.The hlx series operating manual includes some general instructions concerning cleaning.In particular, it is mentioned that "fumigation methods are unsuitable for disinfecting the unit and must not be used.A proposal has been submitted to the hosp to replace the affected parts.

• Brand Name: HLX 3000
• Type of Device: LIGHT, SURGICAL
• Manufacturer (Section D): MAQUET SAS; 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: 4657928
• MDR Text Key: 17688855
• Report Number: 9710055-2015-00033
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H5H3H3
• Device Catalogue Number: 567814341C
• Other Device ID Number: 567910916
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2007
• 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