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 05/20/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On 26th may, 2021 getinge became aware of an issue with examination light ¿ lucea 40.As it was stated, the housing was broken what could have led to the headlight's detachment.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling may lead to serious injury.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with examination light ¿ lucea 40.As it was stated, the housing was broken what could have led to the headlight's detachment.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling may lead to serious injury.It was established that when the event occurred, the light did not meet its specification as the cover was damaged and particles were missing and it contributed to event.There is no information whether the device was or was not being used for patient treatment.The cracks detected at the edge of the fixing holes of transparent housing and handle interface were probably caused by the incompatibility of the cleaning protocol or an abnormal use.The user manual 01701 en 10 page 27 ¿ 29 describes how to clean and disinfect the light heads.This document includes some recommended products and some prohibited products.In order to avoid torques applied on the transparent housing during use, ifu 01701 en 10 page 23-24 mentions to handle the light head by the handle.The cleaning and handling tests performed by getinge (ref.Cre 12-085) did not lead to cracks as reported in the complaints.To prevent similar event the user manual 01701 en 10 page 20 mentions to check the light head during daily inspection.We believe that this type of our devices are performing correctly in the market.

• 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: 11956913
• MDR Text Key: 254848189
• Report Number: 9710055-2021-00214
• 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
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• 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
• Date Manufacturer Received: 06/25/2021
• Patient Sequence Number: 1