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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS HANAULUX 2000 LAMP, SURGICAL

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MAQUET SAS HANAULUX 2000 LAMP, SURGICAL Back to Search Results
Model Number HM56067730
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/31/2021
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) 2021 getinge became aware of an issue with one of surgical lights - hanaulux 2000. The safety ring on spring arm was missing. There was no injury reported however we decided to report the issue based on the potential as lack of safety ring may leads to detachment of light head, moreover, fall of any parts into sterile field may leads to contamination.
 
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Brand NameHANAULUX 2000
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 Key11964135
MDR Text Key255069990
Report Number9710055-2021-00215
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHM56067730
Device Catalogue NumberHM56067730
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/19/1995
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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