MAUDE Adverse Event Report: MAQUET SAS POWERLED 500; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568350908

Device Problems Peeled/Delaminated (1454); Scratched Material (3020)

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

Event Date 10/18/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 getinge became aware of an issue with one of surgical lights - configuration of two powerled 500.During the preventive maintenance the scratches and paint chips were found on the forks.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.

Manufacturer Narrative

Event site telephone: (b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - configuration of three powerled 500.During the preventive maintenance the scratches and paint chips were found on the forks.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.Based on an information gathered, paint scratches was masked by getinge paint chip pen.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification, due to paint chips found on the forks, which could be considered as technical deficiencies, and in this way the device contributed to the event.Provided information indicates that upon the event occurrence, the device was not being used for patient treatment.Based on an information gathered, defect was discovered during preventive maintenance.When reviewing similar reportable events for the same device type, it was confirmed that in the last 5 years, registered for the issue of paint peeling on powerled and hled surgical lights, there is one event which led to the serious injury.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.A root cause analysis for paint peeling problem was performed by subject matter experts and 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 (powerled¿s ifu 01581 rev.9, page 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 (powerled¿s ifu 01581 rev.9, page 27).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 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.The correction of b5 describe event or problem, d1 brand name, d4 version or model # and d4 catalog # fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 18th october, 2023 getinge became aware of an issue with one of surgical lights - configuration of two powerled 500.During the preventive maintenance the scratches and paint chips were found on the forks.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.Corrected b5 describe event or problem: on 18th october, 2023 getinge became aware of an issue with one of surgical lights - configuration of three powerled 500.During the preventive maintenance the scratches and paint chips were found on the forks.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.Previous d1 brand name powerled 500/500 corrected d1 brand name powerled 500.Previous d4 version or model # ard568422010c corrected d4 version or model # ard568350908.Previous d4 catalog # ard568422010c corrected d4 catalog # ard568350908.

Event Description

On 18th october, 2023 getinge became aware of an issue with one of surgical lights - configuration of three powerled 500.During the preventive maintenance the scratches and paint chips were found on the forks.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.

• Brand Name: POWERLED 500
• 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: 17974167
• MDR Text Key: 326141308
• Report Number: 9710055-2023-00788
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568350908
• Device Catalogue Number: ARD568350908
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/20/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1