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

Model Number ARD568370926

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.Device not returned to manufacturer.

Event Description

On 22nd of october 2020 getinge became aware of an issue with one of our surgical light - powerled 700.As it was stated the paint chipping occurred on the fork of the device.Due to this we decided to report this case in abundance of caution and based on potential as any paint particles falling down into sterile filed might led to contamination.Manufacturer's reference number (b)(4).

Manufacturer Narrative

Additional information will be provided upon results of investigation.

Event Description

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

Manufacturer Narrative

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

Event Description

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

Event Description

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

Manufacturer Narrative

On 22nd of october 2020 getinge became aware of an issue with one of our surgical lights - powerled 700.The paint chipping occurred on the device, what was confirmed based on the photo evidence.Due to this, we decided to report this case in abundance of caution and based on potential as any paint particles falling down into sterile filed might led to contamination.The device involved in the event is pwd700df evo video aim lhead v fit k4 w with serial number (b)(6) and catalog number ard568370926.Manufacturing date is 26th february, 2010.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.It is unknown if 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 paint 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.Upon verification of details provided from the service unit with manufacturer's database it deemed required to perform correction of the d4 model # and catalog # sections.D4: previous model # ard267800360a; previous catalog # ard267800360a.Corrected model # ard568370926; corrected catalog # ard568370926.

• Brand Name: POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• MDR Report Key: 10747638
• MDR Text Key: 213438498
• Report Number: 9710055-2020-00450
• 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,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ARD568370926
• Device Catalogue Number: ARD568370926
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1