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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 ARDLCA309009A
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2024
Event Type  malfunction  
Manufacturer Narrative
Event site city: (b)(6).Event site telephone: (b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
 
Event Description
On (b)(6) 2024 getinge became aware of an issue with one of our examination lights ¿ lucea 40 mobile version.As it was stated the light body was damaged, photographic evidence confirmed that issue and indicated that headlight handle was broken and taped with risk of handle detachment and missing particles.There was no injury reported, however we decided to report the issue in abundance of caution as any parts or particles falling off during examination may lead to potential infection of the patient.
 
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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
Manufacturer (Section G)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
Manufacturer Contact
pascal jay
parc de limere
avenue de la pomme de pin
ardon 
MDR Report Key18622718
MDR Text Key334322654
Report Number9710055-2024-00113
Device Sequence Number1
Product Code KZF
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARDLCA309009A
Device Catalogue NumberARDLCA309009A
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/18/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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