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

Catalog Number ARD568350933

Device Problems Device Damaged by Another Device (2915); Device Fell (4014)

Patient Problem 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 being investigated by manufacturing site.(b)(4).

Event Description

On 22nd february, 2018 maquet (b)(4) became aware of an incident with one of surgical lights- powerled.As it was stated, during replacement of spring arm it fell onto floor damaging connectors.There is no injury reported however we decided to report the issue in abundance of caution as any part falling might cause an injury.(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 # (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

Manufacturer reference number: (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.

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).

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 # tw # (b)(4).

Manufacturer Narrative

Getinge became aware of an incident with one of surgical lights- powerled.As it was stated, during replacement of spring arm it fell onto floor damaging connectors.There is no injury reported however we decided to report the issue in abundance of caution as any part falling might cause an injury.It was established that when the event occurred, the light head met its specification and it contributed to the event.At the time when the event occurred the device was not being used for the patient treatment.The manufacturer subject matter experts have investigated the issue.It was established that the issue is related to technician error, as normally during the replacement this part shouldn¿t fall off.The attention should be taken to follow the installation instructions.Given the circumstances and the fact that it is single and isolated event we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

(b)(4).

• Brand Name: POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 8019940
• MDR Text Key: 125640326
• Report Number: 9710055-2018-00149
• 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,health
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 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: ARD568350933
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1