FDA Adverse Event
Malfunction
Summary report: N
SAFETY LIGHT
MDR report key: 2072061
·
Received April 21, 2011
Report
- Report Number
- 1824206-2011-02317
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- November 2, 2010
- Report Date
- March 17, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- KZF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT HAS NOT ALLOWED HILL-ROM TO INSPECT OR INVESTIGATE THE DEVICE.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE OVERBED LIGHT HEATED TO THE POINT OF SMOLDERING, SMOKED AND MELTED THE PLASTIC. NO ACTUAL FLAMES SEEN. THE ACCOUNT INDICATED THERE IS DAMAGE AROUND THE LAMP HOLDERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAFETY LIGHT | AC POWERED MEDICAL EXAM LIGHT | KZF | HILL-ROM, INC. | 640 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |