MAUDE Adverse Event Report: MAQUET SAS LUCEA LED; LAMP, SURGICAL

Model Number LCA50

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Burn(s) (1757)

Event Date 08/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6) 2015 08:26 am (gmt-4:00) added by (b)(6): the maquet fst replaced the power supply board with a new one and returned the device to service.This investigation is on-going and the results will be included in a follow-up report.(b)(4).

Event Description

During a service intervention on a surgical light, a maquet field service technician (fst) received an electric discharge while investigating the power supply board in the ceiling.A burn on his finger was notified.(b)(4).

Manufacturer Narrative

(b)(4).The manufacturer investigated and determined that, although the main power was cut off prior to the manipulations of the power supply, as described in the service manual, the capacitor remained charged.While investigating the power supply in the ceiling, it is likely that the field service technician did not use any personal protection equipment, which led to the reported event.Note: the power supply board is located in a closed enclosure in the ceiling, and can only be accessed by trained service technicians.

Event Description

(b)(4).

• Brand Name: LUCEA LED
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• Manufacturer (Section G): MARIE-FRANÇOISE CABEL - MAQUET SAS; parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; FR 45074
• Manufacturer Contact: parc de limère; avenue de la pomme de pi; orléans cedex 2 45074
• MDR Report Key: 5077879
• MDR Text Key: 25821824
• Report Number: 9710055-2015-01008
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K113679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: LCA50
• Device Catalogue Number: LCA209012C
• Other Device ID Number: 568604956
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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 Outcome(s): Other