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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS POWERLED; LIGHT, SURGICAL, CEILING MOUNTED
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MAQUET SAS POWERLED; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARD568370933
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2024
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
 
Event Description
On 16th february 2024, getinge became aware of an issue with one of surgical lights - powerled 700.As it was stated, the light cover was mouldy which suggest that the water might have been present inside the device.There was no injury reported, however, we decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock.
 
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Brand Name
POWERLED
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 Key18798504
MDR Text Key337626525
Report Number9710055-2024-00183
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Reporter Country CodeAS
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 02/28/2024
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 NumberARD568370933
Device Catalogue NumberARD568370933
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/16/2024
Initial Date FDA Received02/28/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/22/2014
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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