MAUDE Adverse Event Report: MAQUET SAS HANAULUX 2003; LAMP, SURGICAL

Model Number HM56076863

Device Problem Peeled/Delaminated (1454)

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

Event Date 02/11/2022

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 surgical lights - hanaulux 2003.The paint was peeling from the device.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

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

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - hanaulux 2003.The paint was peeling from the device.We decided to report the issue in abundance of caution as any particles falling off into the sterile field or during the procedure may cause contamination.Based on the information provided by the ssu, the offer for repair has been proposed to the customer, however, the customer considers replacement of whole surgical light.The discussion regarding the replacement of surgical light with newer model is ongoing.The customer was advised by the service to not use the device till it will be repaired or replaced, due to the potential risk of paint particles falling into the sterile field.It was established that when the event occurred, the surgical light did not meet its specification due to paint peeling, which contributed to the event.Provided information indicate that upon the event occurrence the device was not being used for patient treatment.Review of received customer product complaints related to investigated issue, revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.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 requirements for all painted parts.Disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.As stated by subject matter expert on manufacturer¿s site, this event is clearly due to cleaning product.Nevertheless, the deterioration of this paint is far advanced and it must have started years ago.Such troubles should have been detected first by the user during daily and monthly checks.The current cleaning product must be improved as described in the user manual.The paint chip or paint damages were also observed as a result of impacts and 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 to detect 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.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendations would have been followed the incident would have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: HANAULUX 2003
• Type of Device: LAMP, SURGICAL
• 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: 13533768
• MDR Text Key: 285612537
• Report Number: 9710055-2022-00064
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HM56076863
• Device Catalogue Number: HM56076863
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/1999
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1