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

Model Number ARD568601998

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

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

Event Date 10/20/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Additional information will be provided following the conclusion of the investigation.

Event Description

On 20th october, 2023 getinge became aware of an issue with one of examination lights - lucea 40 mobile.Based on photographic evidence the headlight cover was cracked with missing particles.We decided to report the issue in abundance of caution as any particles falling off during examination procedure may cause infection.

Manufacturer Narrative

The correction of d4 version of model and catalog # and b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 20th october, 2023 getinge became aware of an issue with one of examination lights - lucea 40 mobile.Based on photographic evidence the headlight cover was cracked with missing particles.We decided to report the issue in abundance of caution as any particles falling off during examination procedure may cause infection.Corrected b5 describe event and problem: on 20th october, 2023 getinge became aware of an issue with one of examination lights - lucea 40 mobile.It was stated the protective cover for the spring arm connection is missing and the power control unit cover is damaged.The designated complaint unit employee confirmed based on photographic evidence the headlight cover was cracked with missing particles.We decided to report the issue in abundance of caution as any particles falling off during examination procedure may cause infection.Previous d4 version of model and d4 catalog # ardlca309009a; corrected d4 version of model and d4 catalog # ard568601998.According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.

Event Description

On 20th october, 2023 getinge became aware of an issue with one of examination lights - lucea 40 mobile.It was stated the protective cover for the spring arm connection is missing and the power control unit cover is damaged.The designated complaint unit employee confirmed based on photographic evidence the headlight cover was cracked with missing particles.We decided to report the issue in abundance of caution as any particles falling off during examination procedure may cause infection.

• Brand Name: LUCEA 40 MOBILE
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 18003168
• MDR Text Key: 326476846
• Report Number: 9710055-2023-00811
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

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: Health Professional
• Device Model Number: ARD568601998
• Device Catalogue Number: ARD568601998
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1