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

Model Number ARD568370939

Device Problem Peeled/Delaminated (1454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Issue is being investigated by manufacturing site.Device not returned to manufacturer.

Event Description

On 2nd september, 2020 getinge became aware of an issue with powerled surgical light.As it was stated, the particles of paint has fallen down into the operating field.We are not aware of any injury this has caused however we decided to report the issu based on the potential.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

On 2nd september, 2020 getinge became aware of an issue with powerled surgical light.As it was stated, the particles of paint has fallen down into the operating field.We are not aware of any injury this has caused however we decided to report the issue based on the potential.The device involved in the event is powerled 700 sf hd r k3 with serial number (b)(6) and catalog number ard568370939.Manufacturing date is 7th december, 2011.It was established that when the event occurred, the surgical light did not meet its specification as the paint chipping could be identified as a technical deficiency.Device which played role in this situation contributed to event.The device was being used for patient treatment while the issue occurred.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.We believe that the 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: POWERLED
• 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: 10493531
• MDR Text Key: 206194666
• Report Number: 9710055-2020-00345
• 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: 12/22/2020

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 Operator: Health Professional
• Device Model Number: ARD568370939
• Device Catalogue Number: ARD568370939
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 09/16/2020; 12/15/2020
• Supplement Dates FDA Received: 10/09/2020; 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1