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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS LUCEA; LIGHT, SURGICAL, FLOOR STANDING
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MAQUET SAS LUCEA; LIGHT, SURGICAL, FLOOR STANDING Back to Search Results
Model Number ARD568601998
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/14/2020
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
 
Event Description
On 14th october, 2020 getinge became aware of an issue with surgical light ¿ lucea.As it was stated, the headlight has detached from the arm.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling may lead to serious injury.
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
 
Event Description
Manufacturer' reference number: (b)(4).
 
Manufacturer Narrative
On 14th october, 2020 getinge became aware of an issue with examination light ¿ lucea 40.As it was stated, the headlight has detached from the arm.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling may lead to serious injury.The device involved in the event is lucea 40 with serial number (b)(6) and catalog number ard568601998.Manufacturing date is 15th of september 2011.It was established that when the event occurred, the examination light did not meet its specification due to headlight detachment and it contributed to the issue.It is unknown if the device was being used for patient examination.During the investigation it was found that the reported scenario has never lead, to date, to serious injury or worse.The manufacturer¿s subject matter experts have investigated the issue.Unfortunately, the specific root cause wasn¿t possible to be established due to lack of information, despite our best efforts.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.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.The correction of b5.Describe event or problem deem required.This is based on the internal evaluation.Previous b5.Describe event or problem: on 14th october, 2020 getinge became aware of an issue with surgical light ¿ lucea.As it was stated, the headlight has detached from the arm.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling may lead to serious injury.Corrected b5.Describe event or problem: on 14th october, 2020 getinge became aware of an issue with examination light ¿ lucea 40.As it was stated, the headlight has detached from the arm.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling may lead to serious injury.
 
Event Description
On 14th october, 2020 getinge became aware of an issue with examination light ¿ lucea 40.As it was stated, the headlight has detached from the arm.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling may lead to serious injury.Manufacturer's reference number (b)(4).
 
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Brand Name
LUCEA
Type of Device
LIGHT, SURGICAL, FLOOR STANDING
Manufacturer (Section D)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
MDR Report Key10753328
MDR Text Key213693365
Report Number9710055-2020-00451
Device Sequence Number1
Product Code FSS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup,Followup
Report Date 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberARD568601998
Device Catalogue NumberARD568601998
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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