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

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.

• Brand Name: TRIANGO 30
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): WALDMANN LIGHTING; 9 west century drive; wheeling IL 60090
• MDR Report Key: 9160836
• MDR Text Key: 161365999
• Report Number: 9160836
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D15174200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6570 DA
• Patient Weight: 64