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

Model Number ARD568423710A

Device Problems Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)

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

Event Date 04/11/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Additional information will be provided following the conclusion of the investigation.

Event Description

On 11th april, 2024 getinge became aware of an issue with one of surgical lights - powerled.It was stated the cover came off again.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.

Manufacturer Narrative

The correction of b5 describe event and problem, h6 medical device ¿ problem code, h6 investigation findings and h6 investigation conclusions, h3a device evaluated by manufacturer?, h3b device not eval provide code deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 11th april, 2024 getinge became aware of an issue with one of surgical lights - powerled.It was stated the cover came off again.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.Corrected b5 describe event and problem: on 11th april, 2024 getinge became aware of an issue with one of surgical lights - powerled.It was stated the cover came off again.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.Further information provided by getinge employee indicated that no cover fell down from the device, the dust cover just came off on one side.Based on that additional input it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of cover's detachment, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Previous h6 medical device ¿ problem code: mechanical problem|detachment of device or device component||2907 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: none previous h6 investigation findings: results pending completion of investigation|||3233 corrected h6 investigation findings: cause traced to component failure||4307 previous h3a device evaluated by manufacturer?: no corrected h3a device evaluated by manufacturer?: yes previous h3b device not eval provide code: device evaluation anticipated, but not yet begun corrected h3b device not eval provide code: blank initially provided information was pointing that the cover came off from the device.The issue is considered as safety related as any parts falling off into sterile field or during procedure may cause contamination or serious injury.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 cover's detachment.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 11th april, 2024 getinge became aware of an issue with one of surgical lights - powerled.It was stated the cover came off again.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.Further information provided by getinge employee indicated that no cover fell down from the device, the dust cover just came off on one side.Based on that additional input it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of cover's detachment, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.

• 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: 19104451
• MDR Text Key: 340138730
• Report Number: 9710055-2024-00268
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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?: No
• Device Model Number: ARD568423710A
• Device Catalogue Number: ARD568423710A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1