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U.S. Department of Health and Human Services

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

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MAQUET SAS POWERLED LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Catalog Number ARD568320905
Device Problems Contamination (1120); Corroded (1131)
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 being investigated by manufacturing site. (b)(4).

 
Event Description

On 11th february, 2018 maquet (b)(4) became aware of an incident with one of surgical lights- powerled. As it was stated, the corrosion occurred on the device. There is no patient involvement however we decided to report the issue in abundance of caution as any rust particle falling 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

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. (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. (b)(4). Exemption # e2018005. (b)(4).

 
Event Description

Ref- (b)(4).

 
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Brand NamePOWERLED
Type of DeviceLIGHT, SURGICAL, CEILING MOUNTED
Manufacturer (Section D)
MAQUET SAS
orléans cedex 2
FR
Manufacturer (Section G)
PASCAL JAY - MAQUET SAS
parc de limère
avenue de la pomme de pi
orléans cedex 2 45074
FR 45074
Manufacturer Contact
parc de limère
avenue de la pomme de pi
orléans cedex 2 45074
0332382587
MDR Report Key8020586
MDR Text Key125662727
Report Number9710055-2018-00162
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
PMA/PMN NumberK070442
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Remedial Action Repair
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/26/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/30/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberARD568320905
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/26/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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