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

Model Number ARD568601999

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/07/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6)2022 getinge became aware of an issue with one of examination lights - lucea 40.It was stated the cover dropped from the headlight.We decided to report the issue in abundance of caution as any parts falling off during examination procedure may cause contamination.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of examination lights - lucea 40.It was stated the cover dropped from the headlight.We decided to report the issue in abundance of caution as any parts falling off during examination procedure may cause contamination.According to the information provided by the getinge service unit, the device has been repaired by installation of a new cover.Required parts were supplied by the customer.Based on the information collected, it was established that when the event occurred, the examination light did not meet its specification, since detachment of cover could be considered as technical deficiency, and in this way the device contributed to the event.The provided information does not indicate if upon the event occurrence the device was or was not being used for treatment or diagnosis purposes.When reviewing reportable events for this type of issue we were able to establish that the received incidents are occurring at a moderate ratio.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.A root cause analysis was performed by subject matter experts at manufacturing site and it was concluded that the pictures of the light head involved were not provided, the expertise of the damages was not performed and the cause of the fall was not identified.In order to avoid mechanical stresses applied on the transparent housing during use the instruction for use ifu 01701 (rev.12, pages 25-26) mentions to handle the light head by the handle.To prevent any incident the instruction for use ifu 01701 (rev.12, pages 20 and 22) indicates: warning! risk of injury/infection the use of a damaged device may lead to a risk of injury for users or a risk of infection for patients.Do not use a damaged device.¿ ¿daily inspections before use integrity of the device 1.Check that the device has not suffered any impact damage.2.Check for any chipped or missing paint.3.If a problem is noted, contact technical support.¿ getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• 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
• 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: 15948081
• MDR Text Key: 305721109
• Report Number: 9710055-2022-00510
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568601999
• Device Catalogue Number: ARD568601999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1