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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDMANN LIGHTING TRIANGO 30 LAMP, SURGICAL

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WALDMANN LIGHTING TRIANGO 30 LAMP, SURGICAL Back to Search Results
Model Number D15174200
Device Problem Device Fell (4014)
Patient Problem No Code Available (3191)
Event Date 07/24/2019
Event Type  malfunction  
Event Description
Rn was moving the wheeled overhead light utilized for post delivery assessment when it became top heavy while being moved into place. It fell onto pt. Bed. The pt. Was in the bed and holding her newborn infant. The light did not strike anyone but frightened all involved. The age of the light is unknown at this writing.
 
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Brand NameTRIANGO 30
Type of DeviceLAMP, SURGICAL
Manufacturer (Section D)
WALDMANN LIGHTING
9 west century drive
wheeling IL 60090
MDR Report Key9160836
MDR Text Key161365999
Report Number9160836
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberD15174200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/04/2019
Event Location Hospital
Date Report to Manufacturer10/07/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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