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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 ARD567932999
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/19/2022
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 surgical lights - hanaulux 3005. It was stated that the handle of the headlight was broken off. We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause 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 Key13897742
MDR Text Key288483601
Report Number9710055-2022-00097
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 03/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberARD567932999
Device Catalogue NumberARD567932999
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/21/2009
Is the Device Single Use? No
Type of Device Usage Reuse

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