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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS HLED; LIGHT, SURGICAL, CEILING MOUNTED
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MAQUET SAS HLED; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARD568334999
Device Problems Crack (1135); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2022
Event Type  malfunction  
Event Description
On 20th october, 2022 getinge became aware of an issue with one of surgical lights - hled 300.It was stated the lines and scratches occurred on the top headlight cover.The designated complaint unit employee confirmed based on photographic evidence the headlight cover was cracked with possibility of missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles 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.H3 other text : device not returned to manufacturer.
 
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Brand Name
HLED
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 Key18533497
MDR Text Key333092462
Report Number9710055-2024-00048
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Reporter Country CodeSP
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 01/18/2024
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 NumberARD568334999
Device Catalogue NumberARD568334999
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/20/2022
Initial Date FDA Received01/18/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/29/2010
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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