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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FREDERIC LELEU - MAQUET SAS ALPHAPORT LAMP, SURGICAL

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FREDERIC LELEU - MAQUET SAS ALPHAPORT LAMP, SURGICAL Back to Search Results
Catalog Number 517001790
Device Problems Corroded (1131); Flaked (1246)
Patient Problem No Information (3190)
Event Date 06/10/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Contact person: (b)(6). The issue is being investigated by manufacturing site.
 
Event Description
On (b)(6) 2018 maquet (b)(4) became aware of an incident with one of devices- alphaport. As stated by the customer, shelf is rusty and the paint is chipping from it. The circumstances of the discover of the issue are unknown. (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. (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). A follow-up medwatch will be submitted when additional information becomes available.
 
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. (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. A follow-up medwatch will be submitted when additional information becomes available.
 
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.
 
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 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).
 
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Brand NameALPHAPORT
Type of DeviceLAMP, SURGICAL
Manufacturer (Section D)
FREDERIC LELEU - MAQUET SAS
parc de limère
avenue de la pomme de pi
orléans cedex 2 45074
FR 45074
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 Key7698300
MDR Text Key114677161
Report Number9710055-2018-00057
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other Health Care Professional
Remedial Action Inspection
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number517001790
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 Received08/16/2018
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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