MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-01 for PHOTOTHERAPY CHAMBER V4472-IV UNKNOWN manufactured by Ultralite Enterprises, Inc..
[15828]
Ultraviolet therapy chamber was cleaned by a maintenance technician. Ultraviolet a & b wave bulbs were removed for cleaning. When bulbs were replaced they were not put in the correct slots thus pts were subjected to incorrect phototherapy dosages. Four pts were given therapy before the bulb mixup was discovered. They all received 1st degree burns. There is no warning on the bulbs or chamber addressing the possibility of bulb mixup. There are only small red dots above the red slots.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 21918 |
| MDR Report Key | 21918 |
| Date Received | 1995-05-01 |
| Date of Report | 1995-05-01 |
| Date of Event | 1995-04-24 |
| Date Facility Aware | 1995-04-26 |
| Date Reported to FDA | 1995-05-01 |
| Date Added to Maude | 1995-05-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PHYSICAL THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHOTOTHERAPY CHAMBER |
| Generic Name | ULTRA VIOLET CHAMBER |
| Product Code | KGL |
| Date Received | 1995-05-01 |
| Model Number | V4472-IV |
| Catalog Number | UNKNOWN |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 11 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 21983 |
| Manufacturer | ULTRALITE ENTERPRISES, INC. |
| Manufacturer Address | 277 INDUSTRIAL PARK DR. LAWRENCEVILLE GA 30245 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-05-01 |