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

Model Number ARD515076999

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2021 getinge became aware of an issue with hled surgical light.According to the photographic evidence the paint chipping occurred, additionally a label was torn with missing particles.There was no injury reported, however, we decided to report the issue based on the potential as paint chipping and torn label with missing particles are creating risk for the patient, as any particles falling into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.The correction of d4 model# and catalog# fields deem required.This is based on the internal evaluation.Previous d4: model#: ard568531710c, catalog#: ard568531710c, corrected d4: model#: ard515076999, catalog#: ard515076999.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - hled.The unit with catalogue number ard515076999 and serial number (b)(6) was manufactured on 27th april, 2010.According to photographic evidence, the paint and label was peeling from the device.There was no injury reported however, we decided to report the issue in abundance of caution as any paint or label particles falling off into sterile field or during procedure may lead to contamination.It was established that when the event occurred, the surgical light did not meet its specification as appearance of chipped paint or label torn are considered as technical deficiency and in this way device contributed to event.We have not received information whether the device was 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.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.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.Minor pain chip can be repaired with touch up paint, nevertheless the parts impacted by serious damage must be replaced.The most probable root cause of torn lable was an excessive and local friction during manipulation of an another device.The hled user manual includes an information to daily check the device for chipped paint and also impact marks and any other damages.Parts which are not up to the manufacturer specification shall be withdrawn from usage until the service operator will recommend to put it back in use.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.Given the circumstances we 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: HLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11372582
• MDR Text Key: 233285383
• Report Number: 9710055-2021-00075
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD515076999
• Device Catalogue Number: ARD515076999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1