MAUDE Adverse Event Report: MAQUET SAS HLED; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568525752A

Device Problems Peeled/Delaminated (1454); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

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

Event Date 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 1st september, 2023 getinge became aware of an issue with one of surgical lights - hled.Based on photographic evidence the paint was chipping from fork and headlight, the label was chipping and it was stated the screws were missing from spring arm.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.

Event Description

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

Manufacturer Narrative

Initial reporter was hospital biomed.The correction of d4 version of model # deems required.This is based on the internal evaluation.Previous d4 version of model # ard568330953/ard568351958.Corrected d4 version of model # ard568525752a.Getinge became aware of an issue with one of surgical lights - hled.Based on photographic evidence the paint was chipping from fork and headlight, the label was chipping and it was stated the screws were missing from spring arm.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification, due to paint peeling from the fork and headlight, label chipping off and missing screw, which could be considered as technical deficiency, and in this way the device contributed to the event.The device was not being used for patient¿s treatment when the event occurrence.When reviewing similar reportable events for the same device type, it was confirmed that in the last 5 years, , there is one event registered for the issue of paint peeling on powerled and hled surgical lights which led to the serious injury.No such events for the issues of label chipping and screw missing.Comparing the number of claimed devices to the number of sold devices worldwide, we can assume that the failure ratio of the paint chipping is moderate, for label chipping or missing is low, and for screw missing is also low.A root cause analysis for paint peeling problem was performed by subject matter experts and they concluded that 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 (ifu 01601 en rev.9, pages 25-27) 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 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.As stated by subject matter expert at the manufacturing site, label peeling is probably due to collision or repeated excessive rubbing during cleaning of the device, the use of aggressive or unsuitable cleaning agents may be a contributing factor.The user manual mentions to check the lightheads for chipped paint, impact marks and any other damages during daily checks (ifu 01601 en rev.9, page 38, 39).As also stated by subject matter experts from the manufacturing site, there is not enough information to establish root cause for missing screw issue.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident could 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.

• Brand Name: HLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• 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: 17735009
• MDR Text Key: 323253264
• Report Number: 9710055-2023-00684
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: TC
• 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
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568525752A
• Device Catalogue Number: ARD568330953/ARD568351958
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1