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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS HLX 3000 LAMP, SURGICAL

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MAQUET SAS HLX 3000 LAMP, SURGICAL Back to Search Results
Model Number HM567823511C
Device Problem Pitted (1460)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2021
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided upon results of investigation. Device not returned to manufacturer.
 
Event Description
On (b)(6) 2021 getinge became aware of an issue with one of our surgical light - hanaulux 3005. During service visit at customer site it has been discovered that rust occurred on the device. Photographic evidence was in line with revealed issue. No information about any injury was provided, however we decided to report this case in abundance of caution as any rust appearance could led to the particles fall from the device and this further could led to contamination.
 
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Brand NameHLX 3000
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 Key11627428
MDR Text Key244200595
Report Number9710055-2021-00127
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHM567823511C
Device Catalogue NumberARD567904999
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/04/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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