InjuryKGL
HOUVA 4
Received May 28, 2015
Report 1521608-2015-00002 · MDR key 4805594
Device
Generic name
Phototherapy Unit
Manufacturer
National Biological Corp.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Burn(s)
- Injury
Narrative
Description of Event or Problem
(B)(4).
Additional Manufacturer Narrative
DURING DISCUSSION WITH (B)(6) CLINICIANS, IT WAS FOUND THAT THE FACILITY WAS NOT FOLLOWING NBC'S RECOMMENDED / PUBLISHED PROTOCOL (KOO). THE FACILITY WAS ADVISED TO UTILIZE ONLY NBC RECOMMENDED AND PUBLISHED PROTOCOLS, AS OUTLINED IN THE IFU, FOR SAFE AND EFFECTIVE TREATMENT. THE FACILITY WAS FOLLOWING ALL OTHER NBC GUIDELINES.
Remedial action
- Inspection