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

Model Number HM567823511C

Device Problem Pitted (1460)

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

Event Date 03/05/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2021 getinge became aware of an issue with one of our surgical light - hanaulux 3005.During service visit at customer site it has been discovered that rust occurred on the device.Photographic evidence was in line with revealed issue.No information about any injury was provided, however we decided to report this case in abundance of caution as any rust appearance could led to the particles fall from the device and this further could led to contamination.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

Manufacturer of model (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical light - hanaulux 3005.During service visit at customer site it has been discovered that rust occurred on the device.Photographic evidence was in line with revealed issue.No information about any injury was provided, however we decided to report this case in abundance of caution as any rust appearance could led to the particles fall from the device and this further could led to contamination.Based on the information collected to date it was established that when the event occurred, the surgical light did not meet the manufacturer¿s specification, since appearance of chipped paint could be considered as technical deficiency, and in this way device contributed to event.There is no information if the device was or was not being used for patient treatment when the event took place.All maquet sas products comply with: ¿ iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.¿ iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.¿ paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.¿ disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.The paint chip or paint damages are due to: impacts, collisions (abnormal use).The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.To prevent any similar incident, it is recommended to avoid the collisions between devices.Visual inspections during the cleaning allow detecting the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor paint chip can be repaired with touch up paint, nevertheless, the parts impacted by serious damage must be replaced.It is also recommended to avoid excessive friction during cleaning or inappropriate cleaning products.Moreover, the most likely root causes of formation of rust are: - higher humiditiy in the operating room, - water ingress.- fumigation treatment.The user manual mentions all the recommendations about the environmental conditions for use and explains how to check the devices during daily inspection.Manufacturer recommends informing the customer about the hazards in cases of non-compliance of these instructions.We believe that remaining devices are performing correctly in the market.Given the circumstances and the fact that there is no apparent trend in complaints of this nature we shall continue to monitor for any further events of this nature and do not propose any further action at this time.The purpose of this submission is also to provide a correction of d4 serial# and catalog# fields.This is based on the result of an internal review noting the report did not contain available information.Previous d4: serial# (b)(6).Catalog# hm567823511c.Corrected d4: serial# (b)(6).Catalog# ard567904999.

Event Description

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

• Brand Name: HLX 3000
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11627428
• MDR Text Key: 244200595
• Report Number: 9710055-2021-00127
• 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: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HM567823511C
• Device Catalogue Number: ARD567904999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/16/2021
• Patient Sequence Number: 1