MAUDE Adverse Event Report: MAQUET SAS HANAULUX 3000; LAMP, SURGICAL

Model Number ARD567902999

Device Problems Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)

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

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2021 getinge became aware of an issue with hanaulux 3000 surgical light.The paint was peeling off the headlight's cover and the handle cracked leading to missing plastic particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any paint or plastic particles falling off into sterile field or during procedure may cause contamination.

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 by the service unit.Previous d4 serial # (b)(6).Corrected d4 serial # (b)(6).

Event Description

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

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with hanaulux 3000 surgical light.The paint was peeling off the headlight's cover and the handle cracked leading to missing plastic particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any paint or plastic particles falling off into sterile field or during procedure may cause contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event.There is no information if upon the event occurrence, from the obtained information, we cannot tell whether or not the device was being used for patient treatment during the investigation, it was found that in the past the reported scenario has never lead to serious injury or worse.When reviewing reportable events for this type of issues we were able to establish that the received incident is occurring at a very low ratio.It is the 4th reported event -worldwide- relating to broken lateral handle and 10th reported event -worldwide- relating to paint peeling, over a high number of devices on the market.The subject matter experts at the manufacturer who investigated the issue found that lateral handles on the device have been damaged because of a shock with another device.The most probable root cause root is misuse.After visual inspection of the pictures, we can see that the light dome has at some point been completely repainted.This operation is not allowed by maquet.The defective components should be replaced by maquet original spare parts only.Therefore, maquet is not responsible for the paint chipping issue.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.

• Brand Name: HANAULUX 3000
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 12031264
• MDR Text Key: 257153124
• Report Number: 9710055-2021-00224
• Device Sequence Number: 1
• Product Code: FTD
• 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: 09/06/2021

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: ARD567902999
• Device Catalogue Number: ARD567902999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 07/16/2021; 08/17/2021
• Supplement Dates FDA Received: 08/10/2021; 09/06/2021
• Patient Sequence Number: 1