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

Model Number ARD568350902

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

Event site name: atrium health carolinas medical additional information will be provided following the conclusion of the investigation.

Event Description

On 16th january, 2024 getinge became aware of an issue with one of surgical lights - powerled 500.It was stated the connection between fork and lighthead was loose with risk of detachment.We decided to report the issue in abundance of caution as loose on connection beetween fork and headlight could lead to fall of the headlight and as a result of that, could lead to serious injury.

Manufacturer Narrative

Initially provided information was pointing to the loose connection between fork and lighthead with risk of detachment.The issue was considered as safety related as loose connection between fork and headlight could lead to fall of the headlight and as a result of that, could lead to serious injury.According to additional clarification provided by the getinge technician, the initial information was incorrect and the issue was related to loose screws securing the ambient light module which were held in place only by the ambient light itself and led modules.It was determined that the issue investigated herein is not safety and risk related as there was no indication of possibilty of parts falling down from this 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 not up to the manufacturer specification due to the issue with ambient light.There is no indication if the device was being used for patient treatment at the time when the event occurred.No apparent reason was identified for suggesting to open a capa or evaluation for the need of another action in the market.The correction of b5 describe event or problem, h6 investigation findings and h6 component codes fields deems required.This is based on the additional information that has been received.Previous b5 describe event or problem: on 16th january, 2024 getinge became aware of an issue with one of surgical lights - powerled 500.It was stated the connection between fork and lighthead was loose with risk of detachment.We decided to report the issue in abundance of caution as loose on connection beetween fork and headlight could lead to fall of the headlight and as a result of that, could lead to serious injury.Corrected b5 describe event or problem: on 16th january, 2024 getinge became aware of an issue with one of surgical lights - powerled 500.It was stated the connection between fork and lighthead was loose with risk of detachment.We decided to report the issue in abundance of caution as loose connection between fork and headlight could lead to fall of the headlight and as a result of that, could lead to serious injury.Further information provided by getinge employee indicated which part was affected.According to the additional clarifications received, the issue was related to loose screws securing the ambient light module which were held in place only by the ambient light itselt and led modules.According to the subject matter expert's assessment, no information indicating loose connection on the fork was provided.Ambient light module is located inside the device and is covered by the transparent underside cover.Therefore, it has been concluded that there was no risk that the light head, ambient light or fixation screws could fall down from the device.Based on the additional input, it was possible to determine that the issue investigated herein is not safety and risk related, as there was no risk of headlight detachment, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Previous h6 investigation findings: results pending completion of investigation|||3233 corrected h6 investigation findings: n/a.Previous h6 component codes: mechanical|dome||793.Corrected h6 component codes: mechanical|fastener|screw|568.Optical|light source||4749.

Event Description

On 16th january, 2024 getinge became aware of an issue with one of surgical lights - powerled 500.It was stated the connection between fork and lighthead was loose with risk of detachment.We decided to report the issue in abundance of caution as loose connection between fork and headlight could lead to fall of the headlight and as a result of that, could lead to serious injury.Further information provided by getinge employee indicated which part was affected.According to the additional clarifications received, the issue was related to loose screws securing the ambient light module which were held in place only by the ambient light itself and led modules.According to the subject matter expert's assessment, no information indicating loose connection on the fork was provided.Ambient light module is located inside the device and is covered by the transparent underside cover.Therefore, it has been concluded that there was no risk that the light head, ambient light or fixation screws could fall down from the device.Based on the additional input, it was possible to determine that the issue investigated herein is not safety and risk related, as there was no risk of headlight 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: 19002406
• MDR Text Key: 338885195
• Report Number: 9710055-2024-00235
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

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 Model Number: ARD568350902
• Device Catalogue Number: ARD568350902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 05/21/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1