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

Model Number ARDLCA209002A

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 15th april, 2021 getinge became aware of an issue with examination light ¿ lucea 40.The headlight has detached from the arm.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.

Manufacturer Narrative

Getinge became aware of an issue with examination light ¿ lucea 40.The headlight has detached from the arm.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 headlight detached and it contributed to event.There is no information whether the device was or was not being used for patient treatment.Unfortunately, manufacturer did not receive enough information to conduct the technical investigation.It is not possible to determine the root cause and therefore the factory investigation report cannot be performed.In case of new relevant information, the case will be reconsidered.We believe that this type of our devices are performing correctly in the market.

Event Description

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

• Brand Name: LUCEA
• 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: 11693413
• MDR Text Key: 258938694
• Report Number: 9710055-2021-00138
• 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: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARDLCA209002A
• Device Catalogue Number: ARDLCA209002A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/20/2021
• Patient Sequence Number: 1