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

Model Number ARD568370939

Device Problems Material Erosion (1214); Pitted (1460)

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

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.Device not returned to manufacturer.

Event Description

On 3rd of december 2020 getinge became aware of an issue with one of our surgical light - powerled.As it was stated during the service visit at customer site the technician revealed corrosion which occurred on the elements of the device.No information about any injury has been provided, however we decided to report this case in abundance of caution as any particles falling into sterile field might led to contamination.

Manufacturer Narrative

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

Event Description

Manufacturer reference number (b)(4).

Event Description

On (b)(6) 2020 getinge became aware of an issue with one of our surgical light - powerled.As it was stated during the service visit at customer site the technician revealed corrosion, which occurred on the elements of the device.Moreover, the problem with damaged stop screws occurred.No information about any injury has been provided, however we decided to report this case in abundance of caution as any particles falling into sterile field might led to contamination.

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical light - powerled.As it was stated during the service visit at customer site the technician revealed corrosion, which occurred on the elements of the device.Moreover, the problem with damaged stop screws occurred.No information about any injury has been provided, however we decided to report this case in abundance of caution as any particles falling into sterile field might led to contamination.It was established that when the event occurred, the surgical light did not meet its specification, since grinding and corrosion 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 concentration of chemical products and the stagnation of cleaning agent residues on the disinfected surfaces are the main factors leading to the deterioration of surfaces.To avoid paint degradation and corrosion it is recommended to respect the cleaning instructions, avoiding spraying, high concentrations, prolonged exposure to detergents / disinfectants solutions, and to wipe with a dry cloth and to make sure that no liquid residue is left on the device after cleaning.To reduce the appearance of rust or the degradation of the surface, the technical manual mentions in the preventive maintenance to lubricate some parts of device.To prevent any incident the user manuals mention to perform daily inspections in order to detect paint defects, impact marks or other damages.Maquet sas recommends to perform corrective maintenance to rectify the default after its detection.Minor paint chips can be repaired with touch up paint, nevertheless the parts impacted by serious damage must be replaced.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 purpose of this submission is also to provide a correction of describe event or problem section.This is based on the result of an internal review noting the report did not contain available information.#b5: previous describe event or problem: on (b)(6) 2020 getinge became aware of an issue with one of our surgical light - powerled.As it was stated during the service visit at customer site the technician revealed corrosion which occurred on the elements of the device.No information about any injury has been provided, however we decided to report this case in abundance of caution as any particles falling into sterile field might led to contamination.Corrected describe event or problem: on (b)(6) 2020 getinge became aware of an issue with one of our surgical light - powerled.As it was stated during the service visit at customer site the technician revealed corrosion, which occurred on the elements of the device.Moreover, the problem with damaged stop screws occurred.No information about any injury has been provided, however we decided to report this case in abundance of caution as any particles falling into sterile field might led to contamination.

• 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
• MDR Report Key: 11670975
• MDR Text Key: 246000722
• Report Number: 9710055-2021-00133
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD568370939
• Device Catalogue Number: ARD568370939
• Date Manufacturer Received: 09/17/2021
• Patient Sequence Number: 1