FDA Adverse Event
Malfunction
Summary report: N
INTEGRIS LIGHT
MDR report key: 1652593
·
Received April 1, 2010
Report
- Report Number
- 1836145-2010-00002
- Event Type
- Malfunction
- Date Received
- April 1, 2010
- Date of Event
- March 3, 2010
- Report Date
- March 3, 2010
- Manufacturer
- HILL-ROM CO. INC., HILL-ROM ARCHITECTURAL PRODUCTS
- Product Code
- KZF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN INVESTIGATED AND FOUND THAT THE UPPER LIGHT LENS WAS MELTED BECAUSE AFTER APPROXIMATELY 15 YRS OF HEAT RISING INTO THE UPPER LENS, THE LENS DRY-ROTTED, CRACKED, TOUCHED THE BULB AND MELTED. NO PATIENTS INJURED.
Description of Event or Problem · 1
ACCOUNT STATED THAT THE LENS ON THE INDIRECT LIGHT OF P696 LIGHT HAS COME INTO CONTACT WITH THE FLUORESCENT BULB AND HAS MELTED HOLE THE SIZE OF A QUARTER IN THE LENS. LENS HAS ALREADY BEEN REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRIS LIGHT | AC POWERED MEDICAL EXAM LIGHT | KZF | HILL-ROM CO. INC., HILL-ROM ARCHITECTURAL PRODUCTS | P696-IL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |