MAUDE Adverse Event Report: MAQUET SAS HLED 500; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568357999

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/22/2022

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) 2022 getinge became aware of an issue with one of surgical lights - hled.It was stated the oil was coming out from the spring arm.We decided to report the issue in abundance of caution as oil falling off into sterile field or during procedure may cause contamination.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of the surgical lights - hled 500.It was stated oil was coming out of the spring arm.We decided to report the issue in abundance of caution as oil falling off into sterile field or during procedure may cause contamination.According to the information obtained from the getinge service technician, the device has been cleaned and returned to use.It was established that when the event occurred, the surgical light did not meet its specification due to oil leakage from hled surgical light, which contributed to the event.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.During the investigation, it was found that in the past the reported scenario has never lead to serious injury nor death.Comparing the number of involved devices to the install base, we conclude that the failure ratio is for the allegation of oil leakage is low.As stated by the subject matter expert at the manufacturer¿s site, during the assembly of spring arms the supplier applies a creamed grease turning into liquid above 135°c.So, the black dripping liquid observed cannot come from the spring arm itself but finds its origin elsewhere.The first cause is a combination of air conditioning and an excess of oil at the bushing location between the spring arm and the main arm.And according to the latest technical investigations carried out in august 2020 at maquet sas the second probable root cause would be an excess of cleaning product in the lower part of the spring arm, applied in spray or with a sponge, but not in compliance with the recommendations given in our user manual.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident would have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.The correction of d4 serial # field deems required.This is based on the internal evaluation.Previous d4 serial # (b)(6).Corrected d4 serial # (b)(6).

• Brand Name: HLED 500
• 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: 16059216
• MDR Text Key: 306902207
• Report Number: 9710055-2022-00548
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568357999
• Device Catalogue Number: ARD568357999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/29/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1