MAUDE Adverse Event Report: MAQUET SAS LUCEA 40; DEVICE, MEDICAL EXAMINATION, AC POWERED

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

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 lucea 40 light.As it was stated, the spring arm's cover cap was missing.There was no injury reported, however we decided to report the issue in abundance of caution as any parts falling off may cause potential infection.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with lucea 40 light.As it was stated, the spring arm's cover cap was missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off may cause potential infection.It was established that when the event occurred, the surgical light did not meet its specification as spring arm¿s cover cap was missing.The device contributed to the issue.There is no information if in the time of event the device was or was not being used for patient treatment.Subject matter experts conducted the analysis for this case.The most probable root cause of the break of this cap is repeated and violent shocks during the use of the device.Another probable root cause is that the cap has been forgotten or deteriorated after a re-adjustment of the spring arm during the maintenance of medical device.The yearly preventive maintenance program documented in the technical manuals mentions to check the presence and fixing of the plastic covers.The cap must be reinstalled during installation or after the maintenance procedure.We strongly advise to check similar devices in the hospital in order to check the presence of all spring arms caps.If a missing cap is noticed, a new one should be ordered as spare parts.(blue 30 / lucea 40-50 : ard569010102).We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

• Brand Name: LUCEA 40
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11272441
• MDR Text Key: 230084022
• Report Number: 9710055-2021-00040
• Device Sequence Number: 1
• Product Code: KZF
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1