FDA Adverse Event
Injury
Summary report: N
BILIBLANKET PLUS PHOTOTHERAPY SYSTEM
MDR report key: 375982
·
Received January 11, 2002
Report
- Report Number
- 1121732-2002-00001
- Event Type
- Injury
- Date Received
- January 11, 2002
- Date of Event
- November 28, 2001
- Manufacturer
- OHMEDA MEDICAL
- Product Code
- LBI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TRANSILLUMINATOR ON THE SUBJECT DEVICE WAS BEING USED IN CONJUNCTION WITH ARTERY LINE PLACEMENT ON A PATIENT. AFTER 0.5 TO 1 MINUTE, A FIRST DEGREE BURN WAS DISCOVERED AT THE SITE WHERE THE TRANSILLUMINATOR HAD TOUCHED THE SKIN. THE INJURY WAS TREATED WITH "STANDARD LOCAL TREATMENT OF BURN INJURY" AND THE PATIENT LEFT THE HOSPITAL IN 2002 IN GOOD CONDITION. THE PT HAS SCARS OF THE INJURY ON THE PATIENT'S RIGHT FOREARM AND ANKLE. THE EQUIPMENT WAS CHECKED BY A HOSPITAL BIOMEDICAL ENGINEER WHO FOUND NO PROBLEM WITH THE UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BILIBLANKET PLUS PHOTOTHERAPY SYSTEM | NEONATAL PHOTOTHERAPY | LBI | OHMEDA MEDICAL | BILIBLANKET PLUS W/TRANSILLUMINATOR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 DAY | Required Intervention |