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

Model Number ARD568330953

Device Problems Material Erosion (1214); Peeled/Delaminated (1454)

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

Event Date 08/06/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2021 getinge became aware of an issue with one of surgical lights - hled.During the visit to perform repair it was noticed the paint chipping occurred on the headlight's cover.No information about patient involvement was provided however we decided to report this case in abundance of caution as any paint particles falling off into sterile field may cause contamination.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - hled 300.During the visit to perform repair, it was noticed the paint chipping occurred on the headlight's cover.No information about patient involvement was provided, however we decided to report this case in abundance of caution as any paint particles falling off into sterile field may cause contamination.It is noteworthy that hled 300 does not have the paint covers, but plastic ones, therefore the problem described as ¿paint chipping¿ cannot occur on this device.It is more related to cracks and particles of plastic missing.It was established that when the event occurred, the surgical light did not meet its specification as appearance of cracks and particles missing could be considered as technical deficiency and in this way device contributed to event.There is no information whether 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.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, indicin 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 plastic surfaces, leads 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 and to wipe with a dry cloth and 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.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would have been avoided.Please be advised the correction of h6 medical device ¿ problem code and h6 component codes fields deems required.This is based on the internal evaluation.Previous h6 medical device ¿ problem code: 1454.Corrected h6 medical device ¿ problem code: 1214.Previous h6 component codes: 4768.Corrected h6 component codes: 772.

Event Description

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

• Brand Name: HLED
• 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: 12424808
• MDR Text Key: 269879854
• Report Number: 9710055-2021-00296
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD568330953
• Device Catalogue Number: ARD568330953
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/28/2021
• Patient Sequence Number: 1