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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET S.A.S. HERAEUS HANAULUX LIGHT, SURGICAL, CEILING MOUNTED

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MAQUET S.A.S. HERAEUS HANAULUX LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number 56067730
Device Problems Circuit Failure (1089); Smoking (1585); Device Operates Differently Than Expected (2913); Noise, Audible (3273)
Patient Problem No Information (3190)
Event Date 12/23/2015
Event Type  Malfunction  
Event Description

During a surgery the arm of the surgical light began to crackle and smoke. The light was turned off and this stopped. The patient was not injured. After the surgery the light was turned back on and short circuited. The light no longer works. Investigation reveals that a mechanical stop in the light failed. It is unknown when this stop failed. This stop prevented the light from rotating 360 degrees. Full rotations of the light rotated the internal wiring and weakened it. This led to the light smoking and short circuiting.

 
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Brand NameHERAEUS HANAULUX
Type of DeviceLIGHT, SURGICAL, CEILING MOUNTED
Manufacturer (Section D)
MAQUET S.A.S.
45 barbour pond drive
wayne NJ 07470
MDR Report Key5426816
MDR Text Key37936585
Report Number5426816
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/02/2016,02/03/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/10/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number56067730
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/02/2016
Device Age25 yr
Event Location Hospital
Date Report TO Manufacturer02/02/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 02/10/2016 Patient Sequence Number: 1
Treatment
NO
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