MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-09 for VISIANO 10-1 P S10 D15781000 manufactured by Derungs Licht Ag.
[182556011]
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. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9805099 |
| MDR Report Key | 9805099 |
| Date Received | 2020-03-09 |
| Date of Report | 2019-01-10 |
| Date of Event | 2019-12-09 |
| Report Date | 2020-01-10 |
| Date Reported to FDA | 2020-01-10 |
| Date Reported to Mfgr | 2020-03-09 |
| Date Added to Maude | 2020-03-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISIANO 10-1 |
| Generic Name | DEVICE, MEDICAL EXAMINATION, AC POWERED |
| Product Code | KZF |
| Date Received | 2020-03-09 |
| Model Number | P S10 |
| Catalog Number | D15781000 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DERUNGS LICHT AG |
| Manufacturer Address | 9 W CENTURY DR WHEELING IL 60090 US 60090 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-09 |