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

Catalog Number ARD568601998

Device Problems Pitted (1460); Detachment of Device or Device Component (2907)

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

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 20th of march 2021 getinge became aware of an issue with one of our surgical light.As it was stated rust occured on the spring arms of the device.No information about any injury has been provided however we decided to report this case in abundance of caution as any rust particles falling into sterile field might led to contamination.

Manufacturer Narrative

Additional information will be provided upon results of investigation.

Event Description

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

Event Description

On 20th of march 2021 getinge became aware of an issue with one of our surgical light.As it was stated rust occured on the spring arms of the device and label was missing.No information about any injury has been provided however we decided to report this case in abundance of caution as any rust particles or label parts falling into sterile field might led to contamination.

Manufacturer Narrative

Additional information will be provided upon results of investigation.The correction of b5 "describe event or problem" field deems required.This is based on the internal evaluation.Previous b5: on 20th of march 2021 getinge became aware of an issue with one of our surgical light.As it was stated rust occured on the spring arms of the device.No information about any injury has been provided however we decided to report this case in abundance of caution as any rust particles falling into sterile field might led to contamination.Corrected b5: on 20th of march 2021 getinge became aware of an issue with one of our surgical light.As it was stated rust occured on the spring arms of the device and label was missing.No information about any injury has been provided however we decided to report this case in abundance of caution as any rust particles or label parts falling into sterile field might led to contamination.

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical lights - hled.As it was stated rust occurred on the spring arms of the device and label was missing.No information about any injury has been provided however we decided to report this case in abundance of caution as any rust particles or label parts falling into sterile field might led to contamination.The repair was offered to the customer, however, the customer declined.It was established that when the event occurred, the surgical light did not meet its specification due to corrosion and missing label, which contributed to the event.Provided information do not indicate if upon the event occurrence the device was being used for patient treatment.Review of received customer product complaints related to 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 claimed devices to number of sold devices worldwide, we can assume that the failure ratio of corrosion occurrence is low and the failure ratio of missing label is very low.To prevent any incident due to paint chipping and corrosion, hled user manual mentions to perform daily inspection in order to check the presence of paint chip, impact marks or other damage.What is more, the same manual mentions that fumigation methods must not be used for cleaning purposes.The label peeling off is probably due to excessive friction during cleaning or inappropriate cleaning products and the hard knocks which could cause scratches, chips and other damages.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.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

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

• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• 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: 11567815
• MDR Text Key: 242194104
• Report Number: 9710055-2021-00113
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/29/2022

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 Catalogue Number: ARD568601998
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2021
• Initial Date FDA Received: 03/25/2021
• Supplement Dates Manufacturer Received: 04/07/2021; 03/26/2021; 04/21/2022
• Supplement Dates FDA Received: 04/30/2021; 08/04/2021; 04/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/18/2014
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose