MAUDE Adverse Event Report: MAQUET SAS POWERLED 700; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568370906

Device Problems Fluid/Blood Leak (1250); No Apparent Adverse Event (3189)

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

Event Date 12/08/2023

Event Type  malfunction  

Event Description

On 8th december, 2023 getinge became aware of an issue with one of surgical lights - powerled 700.It was stated there was a leak from ceiling.We decided to report the issue in abundance of caution as any liquid falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Event site name: cook childrens health care system.Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Manufacturer Narrative

Initial reporter was biomed.The correction of b5 describe event and problem, h6 medical device ¿ problem code, h6 investigation findings, h6 component codes and h6 investigation conclusions deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 8th december, 2023 getinge became aware of an issue with one of surgical lights - powerled 700.It was stated there was a leak from ceiling.We decided to report the issue in abundance of caution as any liquid falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event and problem: on 8th december, 2023 getinge became aware of an issue with one of surgical lights - powerled 700.It was stated there was a leak from ceiling.We decided to report the issue in abundance of caution as any liquid falling off into sterile field or during procedure may cause contamination.Further information provided by getinge employee on (b)(6) 2024 indicated no fault was found.Based on additional input from getinge employee it was possible to determine that the issue investigated herein is not safety and risk related, as there was the water didn't enter to the lamp, which was initially considered and the light pass all functional testing.Therefore, the scenario described in the record is considered as non-reportable.Previous h6 medical device ¿ problem code: mechanical problem|leak/splash|fluid leak|1250.Corrected h6 medical device ¿ problem code: no apparent adverse event|||3189.Previous h6 investigation findings: results pending completion of investigation|||3233 corrected h6 investigation findings: no device problem found|||213 previous h6 component codes: mechanical|dome||793.Corrected h6 component codes: none.Previous h6 investigation conclusions: conclusion not yet available||11.Corrected h6 investigation conclusions: no problem detected||67.Initial information provided was there was a leak from ceiling.Water entered to lamp call fall to the sterile field and based on risk, is considered as a potentially reportable incident, therefore an incident was reported.According to additional clarification provided by the getinge technician, the initial information was incorrect.It was determined that the issue investigated herein is not safety and risk related as there was no indication of water leak on the device.  the investigation was performed.The investigated scenarios did not cause risk to human life.The review of the customer product complaints, related to investigated issue in time, shows that there is no regular income.It was established that when the event occurred, the device was up to the manufacturer specification and was not being used for patient treatment or diagnosis.No apparent reason was identified for suggesting to open a capa or evaluation for the need of another action in the market.

Event Description

On 8th december, 2023 getinge became aware of an issue with one of surgical lights - powerled 700.It was stated there was a leak from ceiling.We decided to report the issue in abundance of caution as any liquid falling off into sterile field or during procedure may cause contamination.Further information provided by getinge employee on (b)(6) 2024 indicated no fault was found.Based on additional input from getinge employee it was possible to determine that the issue investigated herein is not safety and risk related, as there was the water didn't enter to the lamp, which was initially considered and the light pass all functional testing.Therefore, the scenario described in the record is considered as non-reportable.

• Brand Name: POWERLED 700
• 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: 18308449
• MDR Text Key: 330260730
• Report Number: 9710055-2023-00948
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

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 Model Number: ARD568370906
• Device Catalogue Number: ARD568370906
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/20/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1