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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS LUCEA; LAMP, SURGICAL
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MAQUET SAS LUCEA; LAMP, SURGICAL Back to Search Results
Model Number ARDLCA209015A
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2020
Event Type  malfunction  
Manufacturer Narrative
Issue is being investigated by manufacturing site.Device not returned to manufacturer.
 
Event Description
On 8th may, 2020 getinge became aware of customer product complaint where an issue occurred with one of surgical lights - lucea 50.The lamp was initially diagnosed with problem related to shaking.Further evaluation revealed that it was caused by loose connection between spring arm and main tube (loosened screws).There was no patient injury, however we decided to report the issue in abundance of caution as loosened screws may lead to detachment of the lamp or its components.
 
Event Description
Manufacturer's reference number (b)(4).
 
Manufacturer Narrative
On 8th may, 2020 getinge became aware of customer product complaint where an issue occurred with one of surgical lights - lucea 50.The lamp was initially diagnosed with problem related to shaking.Further evaluation revealed that it was caused by loose connection between spring arm and main tube (loosened screws).There was no patient injury, however we decided to report the issue in abundance of caution as loosened screws may lead to detachment of the lamp or its components.It was established that when the event occurred, the surgical light did not meet its specification 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 evaluated case is first one in the history and has not led to serious injury nor death.It is indicated by our product experts the fault of loosened screw occurred due to service error during installation.We believe that all remaining devices are performing correctly in the market.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.
 
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Brand Name
LUCEA
Type of Device
LAMP, SURGICAL
Manufacturer (Section D)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
MDR Report Key10085132
MDR Text Key192043256
Report Number9710055-2020-00161
Device Sequence Number1
Product Code FTD
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 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberARDLCA209015A
Device Catalogue NumberARDLCA209015A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 05/08/2020
Initial Date FDA Received05/25/2020
Supplement Dates Manufacturer Received07/16/2020
Supplement Dates FDA Received07/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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