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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS HLX 3004/ HLX 3005 LAMP, SURGICAL

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MAQUET SAS HLX 3004/ HLX 3005 LAMP, SURGICAL Back to Search Results
Model Number ARD567905999/ARD567904999
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2022
Event Type  malfunction  
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Brand NameHLX 3004/ HLX 3005
Type of DeviceLAMP, SURGICAL
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 
MDR Report Key14885036
Report Number9710055-2022-00252
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodePO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberARD567905999/ARD567904999
Device Catalogue NumberARD567905999/ARD567904999
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/08/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/04/2005
Is the Device Single Use? No
Type of Device Usage Reuse

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