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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS POWERLED 300; LIGHT, SURGICAL, CEILING MOUNTED
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MAQUET SAS POWERLED 300; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARD568330999
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/11/2024
Event Type  malfunction  
Event Description
On 11th april, 2024 getinge became aware of an issue with one of surgical lights - powerled 300.As it was stated, the tabs were missing from spring arm.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination in case of reoccurrence.
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
 
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Brand Name
POWERLED 300
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 Key19115235
MDR Text Key340268172
Report Number9710055-2024-00277
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 04/16/2024
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 Model NumberARD568330999
Device Catalogue NumberARD568330999
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/11/2024
Initial Date FDA Received04/16/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/28/2011
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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