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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS HLED; LIGHT, SURGICAL
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MAQUET SAS HLED; LIGHT, SURGICAL Back to Search Results
Model Number HLED 53SF S
Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Patient Involvement (2645)
Event Date 02/20/2015
Event Type  malfunction  
Event Description
The customer reported to maquet that the cover from the s-suspension fell down during a cleaning procedure.No injury has been reported.(b)(4).
 
Manufacturer Narrative
A maquet service technician inspected the device and found that a plastic cover at the suspension was broken and he replaced the cover with a new one.After the investigation, maquet determined that the most probable cause of the plastic cover falling can be related to an excessive tightening of the screws during installation, leading to the cover breakage around the screws, and combined with collision on this cover.
 
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Brand Name
HLED
Type of Device
LIGHT, SURGICAL
Manufacturer (Section D)
MAQUET SAS
orleans
FR 
Manufacturer Contact
marie-francoise cabel
parc de limere
avenue de la pomme de pin
ardon, orleans cedex 2 45074
FR   45074
37013004
MDR Report Key4628058
MDR Text Key5572809
Report Number9710055-2015-00029
Device Sequence Number1
Product Code BYX
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 02/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberHLED 53SF S
Device Catalogue Number568510714C
Other Device ID Number567501281
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/20/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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