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U.S. Department of Health and Human Services

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

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MAQUET SAS ALM LIGHT LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Device Problem Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

On (b)(6) 2018 maquet (b)(4) became ware of an incident with one of surgical lights. As it was stated the cap fell off into the sterile field. We do not have indication what device was involved in the event. (b)(4).

 
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Brand NameALM LIGHT
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 Key7396212
MDR Text Key104542299
Report Number9710055-2018-00015
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/04/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2018
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

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