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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS HANAULUX 2003 / 2005 LAMP, SURGICAL

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MAQUET SAS HANAULUX 2003 / 2005 LAMP, SURGICAL Back to Search Results
Model Number HM56340538
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2022
Event Type  malfunction  
Event Description
On (b)(6) 2022 getinge became aware of an issue with one of surgical lights - hanaulux 2003 / 2005. It was stated the cover was missing from the spring arm. We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation. Device not returned to manufacturer.
 
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Brand NameHANAULUX 2003 / 2005
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 Key14102429
MDR Text Key289185107
Report Number9710055-2022-00118
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodePO
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
Report Date 04/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberHM56340538
Device Catalogue NumberHM56340538
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Type of Device Usage Reuse

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