SPECTRA 305 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-02 for SPECTRA 305 * manufactured by Daavlin.

Event Text Entries

[56194] Pt entered uvb booth which was set at 400mj (2:54). Pt started uvb. Pta entered the room to monitor time. At 200 mj (1. 27) uvb hold button was pushed. Pt was instructed to put pillow case over face. Resume button was pushed and pta left rrom. Call light was pulled by pt. Pta entered room and pt stated, "i think i've been in here to long! " pta attempted to push hold button several times, but uvb lights would not shut off. Pta left room and instructed pt to open doors, at which time the lights shut off. Pt notified. After pt left room, pta shut doors on uvb and lights came back on. The only way lights could be shut off was to turn key to off.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	97548
MDR Report Key	97548
Date Received	1994-08-02
Date of Report	1994-01-10
Date of Event	1993-12-09
Date Facility Aware	1993-12-09
Report Date	1994-01-10
Date Reported to Mfgr	1994-01-10
Date Added to Maude	1997-06-13
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Reporter Occupation	RISK MANAGER
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	SPECTRA 305
Generic Name	ULTRAVIOLET TOOTH
Product Code	IOB
Date Received	1994-08-02
Model Number	SPECTRA 305
Catalog Number	*
Lot Number	*
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Device Age	2 YR
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	96255
Manufacturer	DAAVLIN
Manufacturer Address	PO BOX 626 BRYAN OH 43506 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-08-02