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

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue is investigated by manufacturing site.

Event Description

On (b)(6) 2018 maquet (b)(4) became aware of an incident with one of surgical lights- lucea 40.As it was stated, the screws which are tightened to light head cover have sheared and fell off.The issue occurred during cleaning of the light.There is no injury reported and no consequences to patient.(b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

(b)(4).Exemption # e2018005.(b)(4).The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

(b)(4).Exemption # e2018005.(b)(4).The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

(b)(4).Exemption # e2018005.(b)(4).The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

(b)(4).Exemption # e2018005.(b)(4).The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

(b)(4).Exemption # e2018005.(b)(4).As stated by the customer there was no impact done to the part and he handles the cupola by its handle.The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The root cause of the issue is established by manufacturing site however, it needs to be confirmed.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, parc de limère, avenue de la pomme de pi orléans cedex 2, france 45074.Exemption # e2018005.Getinge usa sales, llc 45 barbour pond drive wayne, nj 07470.Contact person: (b)(6).Common device name has been corrected to kzf procode.With the complaint at hand, we received an information that the screws which are tightened to the light head cover have sheared and fell off due to the light head cover being damaged.The issue occurred during cleaning of the light.There was no injury reported and no consequences to any patient.The purpose of affected screws is to maintain the cover of the light head to the main structure.The device involved in the event is lucea 40.Serial number of the device is (b)(4) and defective part number is ard568601997.Manufacturing date is (b)(6) 2015 and installation date of the device is (b)(6)2017.The investigation into the root cause of the problem occurrence has been performed and concludes that the most likely root causes of the breakage of the cover and, consequently, screws detachment are repetitive shock during use, too much force used to tightened screws or incompatible cleaning products.In summary and based on the information available to date, when the event occurred, the device was not being used for the patient treatment but it did play a role in the reported event.Performed evaluation of the involved device allowed to establish that it failed to meet the manufacturer specification.Although no injury occurred as a result of this event it was decided to report based on the potential and in abundance of caution.Given the circumstances and the fact that the issue is found to be isolated event getinge does not propose any further action at this time.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: LUCEA 40
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 7468181
• MDR Text Key: 106976776
• Report Number: 9710055-2018-00022
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• PMA/PMN Number: K113679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/06/2019

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 Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 04/04/2018; 04/04/2018; 04/04/2018; 04/04/2018; 04/04/2018; 09/03/2018; 09/28/2018; 10/24/2018; 10/24/2018; 10/24/2018; 10/24/2018; 10/24/2018; 10/24/2018; 10/24/2018; 10/24/2018; 10/24/2018
• Supplement Dates FDA Received: 05/24/2018; 06/18/2018; 07/12/2018; 08/07/2018; 09/05/2018; 09/28/2018; 10/24/2018; 11/16/2018; 12/12/2018; 01/04/2019; 01/29/2019; 02/22/2019; 03/19/2019; 04/12/2019; 05/07/2019; 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1