VISIANO 10-1
Received Mar 9, 2020 · Event occurred Dec 9, 2019
Report 9805099 · MDR key 9805099
Device
Generic name
Device, Medical Examination, Ac Powered
Manufacturer
Derungs Licht AgModel number
P S10Catalog number
D15781000
Product problems
- Melted
- Material Deformation
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
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."