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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS MAQUET X-TEN SURGICAL LIGHT LAMP, SURGICAL

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MAQUET SAS MAQUET X-TEN SURGICAL LIGHT LAMP, SURGICAL Back to Search Results
Model Number ARD567801094
Device Problem Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/07/2019
Event Type  malfunction  
Event Description
The surgeon was positioning the surgical light when the light head fell off the spring arm. He was able to deflect the light head away from the patient as it fell. The patient was not injured during this event.
 
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Brand NameMAQUET X-TEN SURGICAL LIGHT
Type of DeviceLAMP, SURGICAL
Manufacturer (Section D)
MAQUET SAS
MDR Report Key8416626
MDR Text Key138816664
Report NumberMW5084868
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 03/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberARD567801094
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/12/2019 Patient Sequence Number: 1
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