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

Model Number ARD568370906

Device Problem Peeled/Delaminated (1454)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of surgical lights - powerled 700.As it was stated, the joint between spring arm and fork was loose due to the loosening of the screws.There was no risk of the lamp falling.The designated complaint unit employee found out on the photographic evidence the paint was damaged on the spring arm with risk of particles falling.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 in case of reoccurrence.

Manufacturer Narrative

The initial reporter was technical service.The correction of b5 describe event and problem, h3a device evaluated by manufacturer, h3b device not eval provide code and h3c if other provide code -explain fields deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 21st december, 2022 getinge became aware of an issue with one of surgical lights - powerled 700.As it was stated, the joint between spring arm and fork was loose due to the loosening of the screws.There was no risk of the lamp falling.The designated complaint unit employee found out on the photographic evidence the paint was damaged on the spring arm with risk of particles falling.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 in case of reoccurrence.Corrected b5 describe event and problem: on 21st december, 2022 getinge became aware of an issue with one of surgical lights - powerled 700.The received customer allegation regarded a non-reportable issue.The designated complaint unit employee found out on the photographic evidence the paint was damaged on the spring arm with risk of particles falling.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 in case of reoccurrence.Previous h3a device evaluated by manufacturer?: no corrected h3a device evaluated by manufacturer?: yes previous h3b device not eval provide code: other corrected h3b device not eval provide code: n/a previous h3c if other provide code -explain: device not returned to manufacturer corrected h3c if other provide code -explain: n/a.Getinge became aware of an issue with one of surgical lights - powerled 700.The received customer allegation regarded a non-reportable issue.The designated complaint unit employee found out on the photographic evidence the paint was damaged on the spring arm with risk of particles falling.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 in case of reoccurrence.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, which could be considered as technical deficiency, and in this way the device contributed to the event.Provided information does not indicate, if the device was, or was not being used for patient treatment.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 includes the instructions to pre-position the arms prior to use, in order to prevent damages.In all our user manuals, it is mentioned to check the light heads for chipped paint, impact marks and any other damage.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.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

On 21st december, 2022 getinge became aware of an issue with one of surgical lights - powerled 700.The received customer allegation regarded a non-reportable issue.The designated complaint unit employee found out on the photographic evidence the paint was damaged on the spring arm with risk of particles falling.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 in case of reoccurrence.

• 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: 18418201
• MDR Text Key: 331591791
• Report Number: 9710055-2023-00993
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568370906
• Device Catalogue Number: ARD568370906
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 05/16/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1