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

Model Number P S10

Device Problems Melted (1385); Material Deformation (2976)

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

Event Date 12/09/2019

Event Type  malfunction  

Event Description

Clinical engineering technician notes - "i found 10 out of 22 giraffe incubator/warmer exam lights, which are mounted on most giraffe that were melted and deformed due to being left under the radiant warmer.In some cases the exam light was melted so bad that the inside of the lamp was exposed.Another concern is that the fumes from melting plastic can be harmful to patients.I found 2 of 7 in one nicu room were melted, 5 of 10 in another room were melted, 2 of 4 in one intensive care unit were melted, and i found one in the 2nd floor storage area (by the pharmacy) that was melted.".

• Brand Name: VISIANO 10-1
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): DERUNGS LICHT AG; 9 w century dr; wheeling IL 60090
• MDR Report Key: 9805099
• MDR Text Key: 182556011
• Report Number: 9805099
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2020,01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P S10
• Device Catalogue Number: D15781000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2020
• Type of Device Usage: N
• Patient Sequence Number: 1