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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 ARD567501970
Device Problems Crack (1135); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2021
Event Type  Malfunction  
Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation. Device not returned to manufacturer.

 
Event Description

On 25th january, 2021 getinge became aware of an issue with one of surgical lights - axcel. As it was stated, during the medical procedure with a patient, while a movement of the headlight was initiated, the connection between a fork and a headlight broke and the headlight fell off. There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off may lead to serious injury or worse.

 
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Brand NameAXCEL
Type of DeviceLIGHT, 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 Key11247344
MDR Text Key229592360
Report Number9710055-2021-00030
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/16/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/28/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberARD567501970
Device Catalogue NumberARD567501970
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/23/2003
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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