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U.S. Department of Health and Human Services

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

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MAQUET SAS LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Catalog Number ARD568801074
Device Problems Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2018
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

On (b)(6) 2018 maquet sas became aware of an incident with one of surgical lights. As it was stated, the handle attached to the monitor holder fell off during operation. There is no injury reported. (b)(4).

 
Manufacturer Narrative

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

 
Event Description

Manufacturer reference number (b)(4).

 
Manufacturer Narrative

(b)(4). Exemption # e2018005. (b)(4). The issue is still being investigated. Additional information will be provided upon results of investigation.

 
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

(b)(4). Exemption # e2018005. (b)(4). 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 most possible root cause has been established however, it needs to be confirmed. (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).

 
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Type of DeviceLIGHT, SURGICAL, CEILING MOUNTED
Manufacturer (Section D)
MAQUET SAS
orléans cedex 2
FR
Manufacturer (Section G)
FREDERIC LELEU - 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 Key7586457
MDR Text Key111095762
Report Number9710055-2018-00042
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/31/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/11/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberARD568801074
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2018
Was Device Evaluated By Manufacturer? Yes
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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