FDA Adverse Event
Other
Summary report: N
HILLROM
MDR report key: 117618
·
Received September 2, 1997
Report
- Report Number
- 117618
- Event Type
- Other
- Date Received
- September 2, 1997
- Date of Event
- August 11, 1997
- Report Date
- September 1, 1997
- Manufacturer
- HILLROM
- Product Code
- FSS
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- NE, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT WAS HAVING HIS TRACHEOSTOMY TUBE CHANGED. EXAM LIGHT USED DURING THE PROCEDURE OVERHEATED AND CAUSED THE PT THIRD DEGREE BURNS TO THE CHEST. BIOMEDICAL ENGINEERING EXAMINED THE LAMP AND FOUND THAT THE DIFFUSER WAS MISSING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HILLROM | EXAM 965 PLUS | FSS | HILLROM | EXAM PLUS 965 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other | BURN TREATED WITH SILVERDINE OINTMENT DAILY. |