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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS HLX 2004 LAMP, SURGICAL

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MAQUET SAS HLX 2004 LAMP, SURGICAL Back to Search Results
Model Number HM56067740
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
On (b)(6), 2021 getinge became aware of an issue with one of surgical lights - hlx 3000. At it was stated the lenses of light were cracked and the particles were missing. We decided to report the issue in abundance of caution as any device particles falling off into sterile field or during procedure may cause contamination.
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation. H device not returned to manufacturer.
 
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Brand NameHLX 2004
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 Key12974066
MDR Text Key282032511
Report Number9710055-2021-00371
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup
Report Date 03/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberHM56067740
Device Catalogue NumberHM56067740
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received02/23/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Type of Device Usage Reuse

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