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U.S. Department of Health and Human Services

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

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MAQUET SAS HANAULUX 2003 LAMP, SURGICAL Back to Search Results
Model Number HM56076863
Device Problem Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2022
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 2003. The paint was peeling from the device. We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
 
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Brand NameHANAULUX 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 Key13533768
MDR Text Key285612537
Report Number9710055-2022-00064
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,Followup,Followup
Report Date 03/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberHM56076863
Device Catalogue NumberHM56076863
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/31/1999
Is the Device Single Use? No
Type of Device Usage Reuse

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