MAUDE Adverse Event Report: MAQUET SAS LUCEA 100; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD368614998

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue is being investigated by manufacturing site.

Event Description

On (b)(6) 2018 maquet sas became aware of an incident with on of surgical lights- lucea 100.As it was stated, paint chipping occurred.The issue will be investigated as any particle falling might be a source of contamination.Manufacturer reference number: (b)(4).

Manufacturer Narrative

The root cause is established by manufacturing site however, it needs to be confirmed.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Maquet sas became aware of an incident with a surgical light lucea device.As it was stated there appears to be an issue with bracket occurred and the paint was also chipping.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.Reviewing the issue we found that maquet sas initiated a design change request #140805 where the manufacturing process of the bracket was modified since march, 2015.However during our investigation it was found that the issue investigated herein appears to be a single isolated event at this time.Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, parc de limère, avenue de la pomme de pi orléans cedex 2, france 45074 exemption # e2018005.Getinge usa sales, llc (b)(4).Contact person: (b)(6).

• Brand Name: LUCEA 100
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 7855069
• MDR Text Key: 119826646
• Report Number: 9710055-2018-00081
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD368614998
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1