Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS HANAULUX 3000; LAMP, SURGICAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET SAS HANAULUX 3000; LAMP, SURGICAL Back to Search Results
Model Number H4H3DFV
Device Problems Detachment of Device or Device Component (2907); Environmental Compatibility Problem (2929)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/10/2015
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2015 11:25 am (gmt-5:00) added by (b)(6) ((b)(4)): a maquet field service technician visited the hospital and found that the spring arm was broken.The light head was kept on the floor by the customer.
 
Event Description
The customer reported that the surgical light fell down just before surgery.No injuries were reported.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HANAULUX 3000
Type of Device
LAMP, SURGICAL
Manufacturer (Section D)
MAQUET SAS
orléans cedex 2
FR 
Manufacturer (Section G)
MARIE-FRANÇOISE CABEL - MAQUET SAS
parc de limère
avenue de la pomme de pi
orléans cedex 2 45074
FR   45074
Manufacturer Contact
parc de limère
avenue de la pomme de pi
orléans cedex 2 45074
MDR Report Key5286086
MDR Text Key33861646
Report Number9710055-2015-01036
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberH4H3DFV
Device Catalogue Number567823311C
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-