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

Catalog Number LUSX10DDFV

Device Problems Peeled/Delaminated (1454); Defective Device (2588)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

We are aware that this is past the 30 day deadline for reporting.In december, 2017 a transfer of dispatch responsibilities for customer product complaints was made within the company¿s departments.As a consequence of those activities it was discovered that in hindsight, some reactive service notifications had not been transferred into our complaint handling system for a limited period of a few months.After we realized this we have reviewed, and have identified the enclosed complaint as being reportable.As a consequence it is being filed late.Efforts were planned and are being taken to address the issue.The issue is still being investigated by manufacturing site.(b)(4).

Event Description

On 6th april, 2018 maquet (b)(4) became aware of an incident with one of surgical lights- x-ten.As it was stated, the paint was chipping.There was no patient involvement however we decided to report the issue in abundance of caution as any paint particle falling might be a source of contamination.(b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

(b)(4).

Manufacturer Narrative

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

Event Description

Ref- tw # (b)(4).

Manufacturer Narrative

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

Event Description

Ref- (b)(4).

Manufacturer Narrative

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

Event Description

Ref- (b)(4).

Manufacturer Narrative

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

Event Description

Ref- (b)(4).

Manufacturer Narrative

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

Event Description

Ref- (b)(4).

Manufacturer Narrative

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

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Ref- (b)(4).

Manufacturer Narrative

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

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Ref- (b)(4).

Manufacturer Narrative

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

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.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)(4).

Event Description

Ref- tw #: (b)(4).

Event Description

Ref- tw # (b)(4).

Manufacturer Narrative

Getinge became aware of an incident with one of surgical lights- x-ten.As it was stated, the paint was chipping.There was no patient involvement however we decided to report the issue in abundance of caution as any paint particle falling might be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event.The provided information did not indicate that the device was being used for patient treatment when the event took place.During the investigation it was found that in the past the reported scenario has never led to serious injury, nor death.The peeled paint is most likely caused by a stagnation of aggressive disinfectant and detergent products due to an inappropriate cleaning or disinfection protocol or weakening paint coat by physical damage.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendations would have been followed the incident could have been avoided.Given the circumstances and the fact that there is no apparent trend in complaints of this nature we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: X-TEN
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 8020591
• MDR Text Key: 125651078
• Report Number: 9710055-2018-00159
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K040735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LUSX10DDFV
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0