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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS LUCEA 40; DEVICE, MEDICAL EXAMINATION, AC POWERED
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MAQUET SAS LUCEA 40; DEVICE, MEDICAL EXAMINATION, AC POWERED Back to Search Results
Model Number ARD568601997
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/09/2020
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
 
Event Description
On 9th of november 2020 getinge became aware of an issue with one of the light ¿ lucea 40.As it was stated the plastic casing of the lucea 40 was broken.Photographic evidence was showing missing plastic particles.No information about any negative outcome was provided however we decided to report this case in abundance of caution as falling plastic particles may lead to contamination.
 
Manufacturer Narrative
On 9th of november 2020 getinge became aware of an issue with one of the light ¿ lucea 40.As it was stated the plastic casing of the lucea 40 was broken.Photographic evidence was showing missing plastic particles.No information about any negative outcome was provided however we decided to report this case in abundance of caution as falling plastic particles may lead to contamination.It was established that when the event occurred, the surgical light did not meet its specification due to crack of cover leading to missing particles and it contributed to event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury nor death.According to the evaluation performed by the manufacturer¿s subject matter experts the probable causes of the breakage is the incompatibility of the cleaning products or abnormal use.Getinge recommends visual inspection before use according to the user technical manual.A daily inspection performed by the user (chipped paint, impact marks and any other damage) will help preventing such event.We believe that all remaining devices are performing correctly in the market.We also believe that if the preventive maintenance would have been followed the incident could have been avoided.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.
 
Event Description
Manufacturer's reference number (b)(4).
 
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Brand Name
LUCEA 40
Type of Device
DEVICE, MEDICAL EXAMINATION, AC POWERED
Manufacturer (Section D)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
MDR Report Key10904944
MDR Text Key219159613
Report Number9710055-2020-00484
Device Sequence Number1
Product Code KZF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberARD568601997
Device Catalogue NumberARD568601997
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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