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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS HLX 2003 LAMP, SURGICAL

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MAQUET SAS HLX 2003 LAMP, SURGICAL Back to Search Results
Catalog Number HM56076863
Device Problem Excessive Heating (4030)
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 10th january, 2022 getinge became aware of an issue with one of surgical lights - hlx 2000. The use of a more powerful bulb than allowed occurred (150w instead of 50w) which caused simmering of device. We decided to report the issue in abundance of caution as the use of a more powerful bulb can lead to patient burn or to the short circuit causing a fire or electric shock.
 
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Brand NameHLX 2003
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 Key13276027
MDR Text Key284124550
Report Number9710055-2022-00014
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 01/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberHM56076863
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received04/15/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/16/1996
Is the Device Single Use? No
Type of Device Usage Reuse

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