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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS PRISMALIX; LIGHT, SURGICAL, CEILING MOUNTED
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MAQUET SAS PRISMALIX; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARD567238998
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/17/2024
Event Type  malfunction  
Event Description
On 17th april 2024 getinge became aware of an issue with one of surgical lights - prismalix.It was stated that fixation screws holding the device main tube were broken.There was no injury reported, however, we decided to report the issue in abundance of caution as broken screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.
 
Manufacturer Narrative
The initial reporter was a getinge employee.Additional information will be provided following the conclusion of the investigation.
 
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Brand Name
PRISMALIX
Type of Device
LIGHT, SURGICAL, CEILING MOUNTED
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 Key19200186
MDR Text Key341238201
Report Number9710055-2024-00305
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Reporter Country CodeFR
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 04/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARD567238998
Device Catalogue NumberARD567238998
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/17/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2004
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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