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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS LUCEA 10; DEVICE, MEDICAL EXAMINATION, AC POWERED

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MAQUET SAS LUCEA 10; DEVICE, MEDICAL EXAMINATION, AC POWERED Back to Search Results
Model Number ARDLCA309008A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2023
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
 
Event Description
On (b)(6) 2023 getinge became aware of an issue with one of examination lights - lucea 10.It was stated the headlight fell down and the on/off switch was missing.We decided to report the issue in abundance of caution as any parts falling off during examination procedure may cause serious injury.
 
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Brand Name
LUCEA 10
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 Key16774331
MDR Text Key314000043
Report Number9710055-2023-00317
Device Sequence Number1
Product Code KZF
Combination Product (y/n)N
Reporter Country CodeHK
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 04/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARDLCA309008A
Device Catalogue NumberARDLCA309008A
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/13/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/25/2019
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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