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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS XTEN LIGHT, SURGICAL, CEILING MOUNTED

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MAQUET SAS XTEN LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number X10DFDUOVMS-S
Device Problems Component Falling (1105); Contamination (1120)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2016
Event Type  Malfunction  
Manufacturer Narrative

The field service technician evaluated the device and found that the bumper was cut. Maquet assumes that the rubber bumper might have been modified by an un-trained personnel after the original installation by maquet. The xten series installation manual includes the instructions to cross the cables inside the bumper. The user manual recommends checking covers and caps during annual maintenances. The fst replaced the video bumper with a new one and returned the device to service.

 
Event Description

During surgery, the video rubber bumper of a surgical light system fell in the sterile field. No injuries were reported. (b)(4).

 
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Brand NameXTEN
Type of DeviceLIGHT, SURGICAL, CEILING MOUNTED
Manufacturer (Section D)
MAQUET SAS
orléans cedex 2
FR
Manufacturer (Section G)
FREDERIC LELEU - MAQUET SAS
parc de limère
avenue de la pomme de pi
orléans cedex 2 45074
FR 45074
Manufacturer Contact
parc de limère
avenue de la pomme de pi
orléans cedex 2 45074
0332382587
MDR Report Key5744727
MDR Text Key48858454
Report Number9710055-2016-00045
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK040735
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 06/02/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/23/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberX10DFDUOVMS-S
Device Catalogue Number568223581C
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/14/2006
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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