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U.S. Department of Health and Human Services

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

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MAQUET SAS HLX 3005 LAMP, SURGICAL Back to Search Results
Model Number ARD567923999
Device Problem Corroded (1131)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/16/2021
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation. Device not returned to manufacturer.
 
Event Description
On (b)(6) 2021 getinge became aware of an issue with one of our surgical lights - hanaulux 3005. The corrosion occurred on the cover. 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 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 Key12218113
MDR Text Key263160221
Report Number9710055-2021-00249
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeTH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 09/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberARD567923999
Device Catalogue NumberARD567923999
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 Received08/16/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/10/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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