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U.S. Department of Health and Human Services

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

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MAQUET SAS HANAULUX 3005 LAMP, SURGICAL Back to Search Results
Catalog Number ARD567904999
Device Problems Corroded (1131); Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation. Device not returned to manufacturer.
 
Event Description
On 30th of june 2021 getinge became aware of an issue with one of our surgical lights - hanaulux 3005. Photographic evidence was showing paint chipping and rust occurrence on the device. No information about any injury was provided, however, we decided to report this case in abundance of caution as fall of any rust and/or paint particles from the device can leads to contamination.
 
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Brand NameHANAULUX 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 Key12134506
MDR Text Key260455134
Report Number9710055-2021-00245
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received07/15/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/25/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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