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

Model Number ARD568370947

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

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

Event Date 04/01/2024

Event Type  malfunction  

Event Description

On 1st april, 2024 getinge became aware of an issue with one of surgical lights - powerled.It was stated the water entered to the power supply unit.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock.

Manufacturer Narrative

Event site name: (b)(6).Additional information will be provided following the conclusion of the investigation.

Event Description

On 1st april, 2024 getinge became aware of an issue with one of surgical lights - powerled.It was stated the water entered to the power supply unit.The water have soften the celling board over time and the celling has fell.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock and any parts falling off into sterile field or during procedure may cause contamination or serious injury.

Manufacturer Narrative

Initial reporter were facility team.The correction of b5 describe event and problem, h6 component codes and h6 medical device ¿ problem code deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 1st april, 2024 getinge became aware of an issue with one of surgical lights - powerled.It was stated the water entered to the power supply unit.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock.Corrected b5 describe event and problem: on 1st april, 2024 getinge became aware of an issue with one of surgical lights - powerled.It was stated the water entered to the power supply unit.The water have soften the celling board over time and the celling has fell.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock and any parts falling off into sterile field or during procedure may cause contamination or serious injury.Previous h6 medical device ¿ problem code : mechanical problem|leak/splash|fluid leak|1250 corrected h6 medical device ¿ problem code : mechanical problem|leak/splash|fluid leak|1250 / mechanical problem|detachment of device or device component||2907 previous h6 component codes : electrical and magnetic|power supply||498 corrected h6 component codes : electrical and magnetic|power supply||498 / others|appropriate term/code not available||4756 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.

• 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: 19104241
• MDR Text Key: 340133017
• Report Number: 9710055-2024-00266
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 04/15/2024

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: ARD568370947
• Device Catalogue Number: ARD568370947
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1