MAUDE Adverse Event Report: MAQUET SAS POWERLED 300; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD569425710C

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

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

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On 8th january, 2024 getinge became aware of an issue with one of surgical lights - configuration of powerled 500 and 300.As it was stated, the plastic top cover of cupola 300 was cracked with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination in case of reoccurrence.

Manufacturer Narrative

The correction of b5 describe event and problem, d1 brand name # and d4 catalog #, d4 serial #, h3a device evaluated by manufacturer?, h3b device not eval provide code and h3c if other provide code -explain fields deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 8th january, 2024 getinge became aware of an issue with one of surgical lights - configuration of powerled 500 and 300.As it was stated, the plastic top cover of cupola 300 was cracked with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination in case of reoccurrence.Corrected b5 describe event and problem: on 8th january, 2024 getinge became aware of an issue with one of surgical lights - powerled 300.As it was stated, the plastic top cover of cupola was cracked with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination in case of reoccurrence.Previous d1 brand name # powerled 500/300 corrected d1 brand name # powerled 300 previous d4 catalog # ard569425710c corrected d4 catalog # ard568333999 previous d4 serial # (b)(6) corrected d4 serial # (b)(6) previous h3a device evaluated by manufacturer?: no corrected h3a device evaluated by manufacturer?: yes previous h3b device not eval provide code: other corrected h3b device not eval provide code: n/a previous h3c if other provide code -explain: device not returned to manufacturer corrected h3c if other provide code -explain: n/a getinge became aware of an issue with one of surgical lights - powerled 300.As it was stated, the plastic top cover of cupola was cracked with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination in case of reoccurrence.Based on an information gathered, defective pwd300 - aluminium top cover ((b)(6)) was replaced.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event due to the cracks in the headlight cover, leading to missing particles.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.A review of received customer product complaints related to the investigated issue revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.Comparing the number of complained devices to the number of sold devices worldwide, we conclude that the failure ratio is moderate.According to the analysis performed by subject matter experts, 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 material 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.As per subject matter experts¿ expertise, 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 plastic surfaces and lead to its degradation.The concentration of chemical products, the stagnation of substance residues on the 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 of cleaning agent with the device and to wipe it with a dry cloth and to make sure no liquid residue is left on the device after cleaning (ifu 01581 rev.09, pages 35-36).User manual for powerled (ifu 01581 rev.09, pages 20-21) also mentions to perform daily inspection in order to check the presence of paint chip, impact marks or other damage.To prevent similar incidents, it is recommended to respect the cleaning instructions and avoid: ¿ prolonged exposure to detergents and disinfectants solutions ¿ high concentrations of cleaning agents ¿ prohibited products.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

On 8th january, 2024 getinge became aware of an issue with one of surgical lights - powerled 300.As it was stated, the plastic top cover of cupola was cracked with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination in case of reoccurrence.

• Brand Name: POWERLED 300
• 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: 18561968
• MDR Text Key: 333442491
• Report Number: 9710055-2024-00067
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

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 Operator: Health Professional
• Device Model Number: ARD569425710C
• Device Catalogue Number: ARD568333999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1