MAUDE Adverse Event Report: MAQUET SAS LUCEA 40; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number ARD568601997

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2021

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 40 light.The crack of a cover occurred, resulting in missing plastic particles.The issue was confirmed by a photographic evidence.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off may cause potential infection.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.The correction of d4 serial # field deems required.This is based on the information provided from the service unit.Previous d4 serial # (b)(6).Corrected d4 serial # (b)(6).

Event Description

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

Event Description

On 17th may 2021, getinge became aware of an issue with lucea 40 light.The crack of a cover and transformer box occurred, resulting in missing plastic particles.Also information that the light fell to the ground was provided.The issue was confirmed by a photographic evidence.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles or parts falling off may cause potential infection.

Manufacturer Narrative

Getinge became aware of an issue with lucea 40 light.The crack of a cover and transformer box occurred, resulting in missing plastic particles.Also information that the light fell to the ground was provided.The issue was confirmed by a photographic evidence.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles or parts falling off may cause potential infection.The replacement of affected part will be done after budget approval.The equipment is out of usage.It was established that when the event occurred, the light did not meet its specification as cupola and transformer box were damaged and in this way device contributed to event.We have not received information whether the device was being used for patient treatment at the time when the event occurred.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.On a lucea 40 mobile the light head and the power box were found broken because the device fell to the floor.This fall is not due to the product instability as the customer pretended.The most probable cause of this fall is a misuse.The test report re20-78b shows that the lucea 40 mobile is compliant to the standard iec 60601-1 ed.3.1 § 9.4.2.2.The user manual indicates how to manipulate safely the device.Moreover, a warning stipulates that the mobile may tip over if a person leans on it.We believe that all remaining devices are performing correctly in the market.Given the circumstances and after our review of complaint ratio behavior of this nature, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.The correction of b5.Describe event or problem deems required.This is based on information provided from service unit.Previous b5.Describe event or problem: on 17th may 2021, getinge became aware of an issue with lucea 40 light.The crack of a cover occurred, resulting in missing plastic particles.The issue was confirmed by a photographic evidence.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off may cause potential infection.Corrected b5.Describe event or problem: on 17th may 2021, getinge became aware of an issue with lucea 40 light.The crack of a cover and transformer box occurred, resulting in missing plastic particles.Also information that the light fell to the ground was provided.The issue was confirmed by a photographic evidence.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles or parts falling off may cause potential infection.

• Brand Name: LUCEA 40
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11847923
• MDR Text Key: 251394758
• Report Number: 9710055-2021-00195
• Device Sequence Number: 1
• Product Code: KZF
• 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,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD568601997
• Device Catalogue Number: ARD568601997
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 05/19/2021; 06/14/2021
• Supplement Dates FDA Received: 06/11/2021; 06/24/2021
• Patient Sequence Number: 1