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U.S. Department of Health and Human Services

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

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MAQUET SAS HANAULUX 2004 LAMP, SURGICAL Back to Search Results
Device Problem Detachment of Device or Device Component (2907)
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 (b)(6) 2022, getinge became aware of an issue with one of our surgical lights ¿ hanaulux 2003. As it was stated, the headlight fell on ground. No injury has been reported due to described issue, however, we decided to report this case based on potential as any part falling down could lead to serious injury.
 
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Brand NameHANAULUX 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 Key13974946
MDR Text Key288370558
Report Number9710055-2022-00101
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
Report Date 04/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received04/06/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Type of Device Usage Reuse

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