MAUDE Adverse Event Report: MAQUET SAS HLX 3005; LAMP, SURGICAL

Model Number ARD56792399

Device Problems Corroded (1131); Peeled/Delaminated (1454)

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

Event Type  malfunction  

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of surgical lights - hlx 3005.It was stated the corrosion has built up on the headlight, the paint was peeling and the label was torn.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

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

Manufacturer Narrative

The correction of d4 serial # and catalog # deems required.This is based on the internal evaluation.Previous d4 serial # (b)(6).Corrected d4 serial # (b)(6).Previous d4 catalog # ard56792399.Corrected d4 catalog # ard567923999.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 - hlx 3005.It was stated the corrosion has built up on the headlight, the paint was peeling and the label was torn.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification due to the corrosion has built up on the headlight, the paint was peeling and the label was torn, which could be considered as technical deficiencies, and in this way the device contributed to the event.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.According to the analysis performed by the subject matter expert, the paint degradation and corrosion are probably due to infiltration and stagnation of aggressive cleaning products caused by inappropriate cleaning.Label peeling is probably due to repeated excessive rubbing during cleaning of the device, the use of aggressive or unsuitable cleaning agents may be a contributing factor.To prevent any incident, the hlx3000 user manual mentions instructions concerning cleaning and disinfection, recommended and prohibited products.To avoid paint degradation and corrosion it is recommended to respect the cleaning instructions avoiding high concentrations, prolonged exposure to detergents / disinfectants solutions, to wipe with a dry cloth and to make sure no liquid residue is left on the device after cleaning.The hlx3000 user manual mentions to check the lightheads for chipped paint, impact marks and any other damages during daily check.(hlx 3000 user manual en 0132102 2g, pages 19-23) we believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation 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's reference number (b)(4).

• Brand Name: HLX 3005
• 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: 14828634
• MDR Text Key: 303232650
• Report Number: 9710055-2022-00236
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: 505
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD56792399
• Device Catalogue Number: ARD567923999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/21/2007
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1