FDA Adverse Event
Malfunction
Summary report: N
OHMEDA MEDICAL SPOT PHOTOTHERAPY LAMP
MDR report key: 2310120
·
Received September 27, 2011
Report
- Report Number
- 2018492-2011-00019
- Event Type
- Malfunction
- Date Received
- September 27, 2011
- Date of Event
- October 6, 2010
- Report Date
- October 7, 2010
- Manufacturer
- PHILIPS BURTON
- Product Code
- LBI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS INCIDENT WAS ORIGINALLY REPORTED ON (B)(6) 2010 ON VOLUNTARY FROM 3500. THE PURPOSE OF THIS REPORT IS TO SUBMIT THE INCIDENT ON THE CORRECT MANDATORY FORM 3500A.
Description of Event or Problem · 1
THE CUSTOMER WAS USING A PHOTOTHERAPY LAMP MFG BY PHILIPS BURTON (FORMALLY BURTON MEDICAL PRODUCTS). THE CUSTOMER HAD REPLACED THE BULB IN THE UNIT WITH A BULB THAT DID NOT MEET THE MANUFACTURER'S SPECIFICATIONS. THE CUSTOMER REPORTED THAT SUBSEQUENT USE OF THE LAMP "BURNED THE BABIES SKIN." THE AVAILABLE INFO DOES NOT INDICATE THAT THERE WAS ANY SERIOUS INJURY OR EMERGENT CARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OHMEDA MEDICAL SPOT PHOTOTHERAPY LAMP | PHOTOTHERAPY LAMP | LBI | PHILIPS BURTON | P/T LT FLOOR 12 V E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |