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

Model Number ARD568330933

Device Problem Peeled/Delaminated (1454)

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

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

O 15th april 2021 getinge became aware of an issue with one of our surgical light - powerled.As it was stated there was an issue with the paint on the device.No information about any injury was provided, however we decided to report this case in abundance of caution as any paint particles falling from the device into sterile filed might led to contamination.

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical light - powerled.As it was stated there was an issue with the paint on the device.No information about any injury was provided, however we decided to report this case in abundance of caution as any paint particles falling from the device into sterile filed might led to contamination.Photographic evidence provided later showed the plastic covers cracked.It was established that when the event occurred, the surgical light did not meet its specification, since appearance of cracks on cover could be considered as technical deficiency, and in this way device contributed to event.We have not received information whether the device was 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.All maquet sas products comply with: ¿ iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.¿ iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.¿ disinfection products test: maquet sas described how to perform the paint resistance test in the working instruction ref.Fl 007.The following disinfection products are tested: surfa¿safe, isopropyl alcohol, incidin pro, virkon.The aim of these tests is to detect any incompatibility with disinfectant.The involved zone was probably exposed and the edges damaged corresponds to a retention zone.These facts indicate that cleaning agent residues may have a negative reaction on the plastic surfaces and leads to its degradation.The concentration of chemical products, the presence of agent residual on the disinfected surfaces are probably the main factors leading to the deterioration of surfaces.To avoid degradation of the shell it is recommended to respect the contact time and to wipe with a dry cloth ad to make sure no liquid residue is left on the device after cleaning.The user manual mentions also to perform daily inspection in order to check the presence of paint chip, impact marks or other damage.To prevent similar incident, it is recommended to respect the cleaning instructions avoiding: - prolonged exposure to detergents and disinfectant solutions; - high concentrations; - prohibited products.Given the circumstances and after our review of complaint ratio behavior of this nature, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manufacturer 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
• MDR Report Key: 11746641
• MDR Text Key: 248208134
• Report Number: 9710055-2021-00157
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD568330933
• Device Catalogue Number: ARD568330933
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/03/2021
• Patient Sequence Number: 1