MAUDE Adverse Event Report: MAQUET SAS HLED; LIGHT, SURGICAL, CEILING MOUNTED

Model Number HLD300SF K4

Device Problems Component Falling (1105); Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2016

Event Type  malfunction  

Manufacturer Narrative

Note: the hled 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.The hospital staff put the cap back in place and returned the device to service.A maquet field service technician (fst) evaluated the device and determined that the most likely cause of this event is a wrong positioning of the cap during a maintenance or a cleaning procedure.The fst did not detect any failures on the cap and found it functional.The yearly maintenance program in the hled operating manual includes a verification of all the covers and caps.

Event Description

The customer reported that the light blue bracket cap felt down during a surgery.The part felt down on the surgical field and no injuries were reported.(b)(4).

• Brand Name: HLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• Manufacturer (Section G): MAQUET SAS; orléans cedex 2 ; FR

orléans cedex 2 

• MDR Report Key: 5785499
• MDR Text Key: 50195123
• Report Number: 9710055-2016-00049
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLD300SF K4
• Device Catalogue Number: 568514110C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2009
• 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
• Patient Age: 79 YR