MAUDE Adverse Event Report: MAQUET SAS POWERLED 700; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568370902

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 09/22/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Event site name: (b)(6).Event site telephone: (b)(6).The initial reporter was getinge technician.H3 other text : device not returned to manufacturer.

Event Description

On 22nd september, 2023 getinge became aware of an issue with one of surgical lights - powerled 700.It was stated the control panel foil was defective.Photographic evidence indicated that control panel membrane was damaged with missing particles, and additionally that the paint on fork was damaged with risk of missing particles.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 or serious injury.

Manufacturer Narrative

The correction of d4 catalog # and serial # deems required.This is based on the internal evaluation.Previous d4 catalog # ard568370902.Corrected d4 catalog # ard568350908/ard568370902.Previous d4 serial #: (b)(6).Corrected d4 serial #: (b)(6).Getinge became aware of an issue with one of surgical lights - powerled 700.It was stated the control panel foil was defective.Photographic evidence indicated that control panel membrane was damaged with missing particles, and additionally that the paint on fork was damaged with risk of missing particles.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 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 forks and damaged keypad membranes with missing particles, which could be considered as technical deficiency, and in this way the device contributed to the event.Provided information does indicate that upon the event occurrence, the device was not being used for patient treatment.The issue was discovered by getinge technician who performed the 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.There is no such event registered for the issue with damaged keypad membrane with missing particles.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 and the failure ratio of damaged keypad membrane with missing particles is low.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.As also stated by subject matter expert at manufacturer¿s site, the keypad peeling off is a normal wear at this location.In the chapter daily inspections before use each user manual mentions to check that the keypad is in good condition (ifu 01581 rev.9, page 22).As soon as a default is noticed on the keypad membrane, its replacement must be performed.The film protection is available as spare part.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.

Event Description

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

• Brand Name: POWERLED 700
• 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: 17815910
• MDR Text Key: 324223767
• Report Number: 9710055-2023-00724
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568370902
• Device Catalogue Number: ARD568350908/ARD568370902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1