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

Model Number ARDPWD259001A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.

Event Description

On 27th of april 2021 getinge became aware of an issue with one of our surgical light - powerled.As it was stated the light head of the device was loose on the connection with its fork and there was a possibility of light head detachment.There was no injury reported however we decided to report the issue based on the potential as a light head falling down might led to serious injury or worse.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.The correction of b5 describe event or problem section deems required.This is based on the information provided from service unit.Previous b5 describe event or problem: on 27th of april 2021 getinge became aware of an issue with one of our surgical light - powerled.As it was stated the light head of the device was loose on the connection with its fork and there was a ppossibility of light head detachment.There was no injury reported however we decided to report the issue based on the potential as a light head falling down might led to serious injury or worse.Corrected b5 describe event or problem: on 27th april, 2021 getinge became aware of an issue with powerled surgical light.The connection between the fork and the headlight was grinding during movement, creating risk of detachment of filings.There was no injury reported however we decided to report the issue based on the potential and any particles falling off into sterile field or during procedure may cause contamination.

Event Description

On 27th april, 2021 getinge became aware of an issue with powerled surgical light.The connection between the fork and the headlight was grinding during movement, creating risk of detachment of filings.There was no injury reported however we decided to report the issue based on the potential and any particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical light - powerled.As it was stated the light head of the device was loose on the connection with its fork and there was a possibility of grinding during movement, creating risk of detachment of filings.There was no injury reported, however, we decided to report the issue based on the potential and any particles falling off into sterile field or during procedure may cause contamination.According to the information provided by the service technician, the device has been repaired by replacement of pwd/hld 700 -rep.Kit for end stop cupola (ard368336556) and pwd fork lexan protection tape kit (ard368331555).It was established that when the event occurred, the surgical light did not meet its specification, since grinding could be considered as technical deficiency, and in this way device contributed to event.There is no information if the device was or was not being used for patient treatment at the time when the event occurred.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.The problem with the stops rotation is due to a lack of contact area between the stops.These stops realized with screw heads seem to be too short and become ineffective over time.The result is that the light can rotate freely, unplugging the cables and eventually creating some metal fillings.In september 2011, maquet sas has changed these screws in the production line but has not noticed any adverse outcome.Before this date, the screws were a bit longer, hence the stops stronger and should not be concerned by this problem.This issue is followed through the capa 464134.The gap between the fork and the headlight was caused by a loosening of the bracket fixing screws over a long period due to a lack of thread-locking patch on three screws in production line (isolated case).To prevent any safety issue the user manual (powerled 01581 rev.9, pages 20-22 and 39) mentions to check the headlights for chipped paint, impact marks and any other damage and to perform yearly preventive maintenance.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manufacturer's reference number (b)(4).

• 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: 11752385
• MDR Text Key: 248188672
• Report Number: 9710055-2021-00166
• 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,Followup,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDPWD259001A
• Device Catalogue Number: ARDPWD259001A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1