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

Catalog Number ARD568370939

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2019

Event Type  malfunction  

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

On (b)(4) 2019 maquet (b)(4) became aware of an issue with one of surgical lights- powerled.As it was stated, the plastic from the keypad cover was bursting.There was no injury reported however we decided to report the issue in abundance of caution as any particle falling into sterile field or during procedure might be a source of contamination.(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.

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 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

Manufacturer reference number #(b)(4).

Manufacturer Narrative

On (b)(6)2019 we became aware of an issue with one of surgical lights- powerled.As it was stated, the plastic from the keypad cover was bursting.There was no injury reported, however we decided to report the issue in abundance of caution as any particle falling into sterile field or during procedure 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.There is no information if during the event occurrence the device was or was not being used for patient treatment.With the complaint at hand, we did not receive any information regarding the cleaning solution used by the customer to clean the device, however the plastic degradation can lead us to the conclusion that it is related to malfunction of the keypad.Therefore, we are able to assume that the most likely root cause of the issue is related to the maintenance of the device itself.It is worth adding, that no service/maintenance history has been obtained for the claimed device.The information how to clean the device is included in instructions for use, provided together with the device to the customer.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.Given the circumstances and the fact that this is the first complaint 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.

Event Description

Manufacturer reference number #195762.

• Brand Name: POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 8366724
• MDR Text Key: 137555465
• Report Number: 9710055-2019-00046
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K070442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ARD568370939
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other