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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 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).

 
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Brand NamePOWERLED
Type of DeviceLIGHT, SURGICAL, CEILING MOUNTED
Manufacturer (Section D)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
Manufacturer (Section G)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
Manufacturer Contact
pascal jay
parc de limere
avenue de la pomme de pin
ardon 
0332382587
MDR Report Key8019940
MDR Text Key125640326
Report Number9710055-2018-00149
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 09/02/2020
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 NumberARD568350933
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 Received08/21/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/22/2016
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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