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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET S.A.S. LUCEA 40 MOBILE; LIGHT, SURGICAL, FLOOR STANDING
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MAQUET S.A.S. LUCEA 40 MOBILE; LIGHT, SURGICAL, FLOOR STANDING Back to Search Results
Model Number LUCEA40
Device Problems Break (1069); Crack (1135); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Patient Involvement (2645)
Event Date 06/21/2019
Event Type  malfunction  
Event Description
Exam lights are frequently sent for repairs.It appears as though the lights are moved by grabbing the head of the light instead of the handle, leading to damage on the casing and transparent cover.This is a recurring problem with this device at this facility.All models are affected.Our facility is sending multiple reports.The devices are available for the manufacturer to inspect.The cracks are occurring in the plastic housing where the screws attach the covering to the frame.Although the age of the original floor model devices range from 2012 to 2017, the case coverings are being replaced much more frequently.There is no labeling or warnings to the end user to indicate that the lights cannot be moved or repositioned by grasping the outer light casing.The lights are located in the ed and the ob units of the facility and are often used for procedures.
 
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Brand Name
LUCEA 40 MOBILE
Type of Device
LIGHT, SURGICAL, FLOOR STANDING
Manufacturer (Section D)
MAQUET S.A.S.
45 barbour pond drive
wayne NJ 07470
MDR Report Key8859506
MDR Text Key153268287
Report Number8859506
Device Sequence Number1
Product Code FSS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2019
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberLUCEA40
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/25/2019
Date Report to Manufacturer08/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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