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

Model Number ARDLCA309009C

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Issue is being investigated by manufacturing site.Device not returned to manufacturer.

Event Description

On 20th may, 2020 getinge became aware of an issue with one of surgical lights - lucea.As it was stated, the cover of lighthead was damaged and cover of spring arm is missing.There was no injury reported however we decided to report the issue in abundance of caution, as any parts falling off may lead to serious injury.

Manufacturer Narrative

Getinge became aware of an issue with a lucea device.As it was stated, the cover of lighthead was damaged and cover of spring arm was missing.There was no injury reported however we decided to report the issue based on the potential related to parts falling into the sterile field, which may be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification as damaged or missing cover could be treated as technical deficiency.The device contributed to event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.Despite the effort made in gathering more detailed information it was not provided.The manufacturer¿s subject matter experts have reviewed the case and unfortunately could not provide the specific root cause which wasn¿t possible to be established.We believe that all remaining devices are performing correctly in the market.Given the circumstances we 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).

• Brand Name: LUCEA
• 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: 10332019
• MDR Text Key: 200608642
• Report Number: 9710055-2020-00229
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARDLCA309009C
• Device Catalogue Number: ARDLCA309009C
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1