SPECTRA-MINI H-F UVA - HO *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-06-02 for SPECTRA-MINI H-F UVA - HO * manufactured by Daavlin Co.

Event Text Entries

[301349] 1) bilateral burns on soles of feet due to ultraviolet-a treatment that should have been 50 sec. In duration and may have been 1 hour. 2) time was incorrectly set when the staff person moved the "second" dial to 50 seconds, then moved the "minute" per counter clockwise 1 notch, thus setting the timer to 59 minutes and 50 seconds. 3) at time of report, pt is hospitalized at a burn treatment facility. 4) pt was scheduled for phototherapy treatment on feet and hands in 2003. This was pt's second treatment for this medical condition. The light box for the pt's feet was set for 59 minutes and 50 seconds instead of the designated 50 seconds. The light box for the pt's hands was set correctly and without incident. Regarding the light box, the user indicated this is a "touchy" light box to work with. Meaning it is difficult to know exactly how much time is set. After verifying that the minutes/seconds were both on "zero", the user turned the seconds' dial clockwise (as is protocol) to 50 seconds. The user checked the minutes' peg to make sure it was still on "zero", since it appeared to be on 1 minute they moved the peg backwards (counter-clockwise) to what they thought was "zero. " in reality, they put the minutes' peg on "59 minutes" with a total time setting of 59 minutes and 50 seconds. The user then turned the light box on and resumed other duties.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 468600
• MDR Report Key: 468600
• Date Received: 2003-06-02
• Date of Report: 2003-06-02
• Date of Event: 2003-05-23
• Date Facility Aware: 2003-05-24
• Report Date: 2003-06-02
• Date Reported to FDA: 2003-06-02
• Date Added to Maude: 2003-07-01
• 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
• 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-MINI
• Generic Name: ULTRAVIOLET - A LIGHT BOX
• Product Code: IOB
• Date Received: 2003-06-02
• Model Number: H-F UVA - HO
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 15 YR
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 457500
• Manufacturer: DAAVLIN CO
• Manufacturer Address: 205 WEST BEMENT ST. BOX 626 BRYAN OH 43506 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2003-06-02