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

Model Number ARD568350909

Device Problems Material Erosion (1214); 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 our surgical lights power led.As it was stated, problems with between fork and headlight connection leading to grinding and paint chipping occurred on the device.There was no injury reported, however 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.

Event Description

On 20th april, 2022 getinge became aware of an issue with one of our surgical lights ¿ powerled.As it was stated, paint chipping occurred on the device.There was no injury reported, however 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

Getinge became aware of an issue with one of our surgical lights ¿ powerled.As it was stated, the paint chipping occurred on the device.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.According to the information provided by the service technician, the proposal of the repair has been offered to the customer, however, the customer did not approve the repair yet.It was established that when the event occurred, the surgical light did not meet its specification, since paint chipping 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 at the time when the event occurred.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.Comparing the number of complained devices to the number of units placed on the market we can conclude the failure ratio is moderate for the issues of paint chipping as stated by subject matter expert at the manufacturing site, 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.According to subject matter expert at manufacturer, 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 (powerled user manual 01581 rev.09, pages 27-29).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 (powerled user manual 01581 rev.09, pages 20-21).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 would have 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, h6 medical device ¿ problem code and h6 component codes fields deems required.This is based on internal evaluation.Previous b5 describe event or problem.On 20th april, 2022 getinge became aware of an issue with one of our surgical lights ¿ powerled.As it was stated, problems with between fork and headlight connection leading to grinding and paint chipping occurred on the device.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event or problem.On 20th april, 2022 getinge became aware of an issue with one of our surgical lights ¿ powerled.As it was stated, paint chipping occurred on the device.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Previous h6 medical device ¿ problem code.Material integrity problem|degraded|peeled/delaminated|1454.Material integrity problem|degraded|material erosion|1214.Corrected h6 medical device ¿ problem code.Material integrity problem|degraded|peeled/delaminated|1454.Previous h6 component codes.Mechanical|coating material||4768.Mechanical|connector/coupler||4733.Corrected h6 component codes.Mechanical|coating material||4768.

• Brand Name: POWERLED
• 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: 14286323
• MDR Text Key: 290784832
• Report Number: 9710055-2022-00143
• Device Sequence Number: 1
• Product Code: FSY
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568350909
• Device Catalogue Number: ARD568350909
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/02/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1