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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS AXCEL; LIGHT, SURGICAL, CEILING MOUNTED
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MAQUET SAS AXCEL; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARD567510900
Device Problems Corroded (1131); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/16/2024
Event Type  malfunction  
Event Description
On 16th april, 2024 getinge became aware of an issue with one of surgical lights - axcel.It was stated the arms were rusty and the cover was missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.
 
Manufacturer Narrative
Event site postal code: (b)(6) , event site name: (b)(6) hospital.Additional information will be provided following the conclusion of the investigation.
 
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Brand Name
AXCEL
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 Key19133605
MDR Text Key340489862
Report Number9710055-2024-00286
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Reporter Country CodePO
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 04/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model NumberARD567510900
Device Catalogue NumberARD567510900
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/16/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2008
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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