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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS POWERLED II; LAMP, SURGICAL
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MAQUET SAS POWERLED II; LAMP, SURGICAL Back to Search Results
Model Number ARDPWT629089A
Device Problem Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Additional information will be provided following the conclusion of the investigation.
 
Event Description
On (b)(6) 2024 getinge became aware of an issue with one of our surgical lights ¿ powerled ii.As it was stated, the paint was damaged during assembly and the device was used after the installation.The designated complaint unit employee confirmed based on photographic evidence that the issue occurred on the fork.There was no injury reported, however, we decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure may cause contamination in case of reoccurrence.
 
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Brand Name
POWERLED II
Type of Device
LAMP, SURGICAL
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 Key19104242
MDR Text Key340133051
Report Number9710055-2024-00267
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeBR
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 04/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model NumberARDPWT629089A
Device Catalogue NumberARDPWT629089A
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/05/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2023
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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