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

Model Number 60170/60708

Device Problems Corroded (1131); Fluid/Blood Leak (1250); Peeled/Delaminated (1454); Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Event Description

On 4th september 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled.Based on photographic evidence the label and the paint was chipping from arm and the water with rust was leaking from the device.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock and any particles falling off into sterile field or during procedure may cause contamination or serious injury.

Manufacturer Narrative

The initial reporter was the getinge technician.Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Manufacturer Narrative

The correction of b5 describe event and problem, d4 serial # and d4 version of model # and d4 catalog # deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 4th september 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled.Based on photographic evidence the label and the paint was chipping from arm and the water with rust was leaking from the device.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock and any particles falling off into sterile field or during procedure may cause contamination or serious injury.Corrected b5 describe event and problem: on 7th july 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled.Based on photographic evidence the label and the paint was chipping from arm and the water with rust was leaking from the device.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock and any particles falling off into sterile field or during procedure may cause contamination or serious injury.Previous d4 serial # (b)(6).Corrected d4 serial # (b)(6).Previous d4 version of model # and d4 catalog # ard568421710c corrected d4 version of model # and d4 catalog # ard568370933/ard568330933 according to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.

Event Description

On 7th july 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled.Based on photographic evidence the label and the paint was chipping from arm and the water with rust was leaking from the device.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock and any particles falling off into sterile field or during procedure may cause contamination or serious injury.

• 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: 17744036
• MDR Text Key: 323381154
• Report Number: 9710055-2023-00698
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 60170/60708
• Device Catalogue Number: ARD568370933/ARD568330933
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1