MAUDE Adverse Event Report: DERUNGS LICHT AG VISIANO 10-1 P; DEVICE, MEDICAL EXAMINATION, AC POWERED

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2019

Event Type  malfunction  

Event Description

The light at the baby's bedside broke in 2 pieces.The overhead exam light and the flex pole broke.There are 5 in our unit and all have been removed for safety issues.

• Brand Name: VISIANO 10-1 P
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): DERUNGS LICHT AG; waldmann lighting; 9 west century drive; wheeling IL 60090
• MDR Report Key: 8508391
• MDR Text Key: 141761737
• Report Number: 8508391
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/03/2019,03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/03/2019
• Date Report to Manufacturer: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1