MAUDE Adverse Event Report: MAQUET SAS LUCEA 100-50; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARDLCA219002A

Device Problems Crack (1135); Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

On (b)(6) 2021 getinge became aware of an issue with lucea 100-50 surgical light.As it was stated, the covers of light heads were broken and particles were missing.Additionally, the paint was peeling from fork.There was no injury reported, however we decided to report the complaint in abundance of caution as any particles or parts falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Getinge became aware of an issue with lucea 100+50 surgical light.As it was stated, the covers of light heads were broken and particles were missing.Additionally, the paint was peeling from fork.There was no injury reported, however we decided to report the complaint in abundance of caution as any particles or parts falling off into sterile field or during procedure may cause contamination.It was established that when the event occurred, the surgical light did not meet its specification as particles of paint and cover were missing, and it contributed to event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.All maquet sas products comply with: iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.Iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.Paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.Disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.The paint chip or paint damages are due to: impacts, collisions (abnormal use).The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.Cover cracking is indicated by our product experts to likely be caused by combination of different factors such as: mechanical stress, environmental conditions (such a high temperature and humidity variations during transport and storage), use of inappropriate cleaning/disinfections products, or inappropriate cleaning and disinfection protocols.To prevent any similar incident, it is recommended to avoid the collisions between devices.Visual inspections during the cleaning allow detecting the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor pain chip can be repaired with touch up paint; nevertheless, the parts impacted by serious damage must be replaced.We believe that overall the devices on the market are performing correctly.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manufacturer's reference number (b)(4).

• Brand Name: LUCEA 100-50
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11348706
• MDR Text Key: 232554379
• Report Number: 9710055-2021-00066
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 3700712400668
• UDI-Public: (01)3700712400668
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARDLCA219002A
• Device Catalogue Number: ARDLCA219002A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1