SUNFIRE 24 DELUXE SF 24 DELUXE CANOPY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-19 for SUNFIRE 24 DELUXE SF 24 DELUXE CANOPY manufactured by Sunfire Industries, Inc.

Event Text Entries

[4422914] On (b)(6) 2014, an anonymous consumer contacted (b)(4) to report that on (b)(6) 2014, he had rec'd a very severe sunburn, from a brand new home tanning bed, after the tanning bed timer failed to turn off the tanning lamps, when the allotted time had passed. On (b)(6) 2014, he purchased a "sunfire24 deluxe" home tanning bed from sunfire industries website (sunfiretanningbeds. Com). He did not know date that he had rec'd the tanning bed, but had assembled the tanning bed without difficulty. On (b)(6) 2014, he decided to use the tanning bed for the first time. He read the manual and followed the directions, he set the timer for nine minutes, and lowered the tanning bed canopy. During the tanning session he fell asleep; he awoke one hour later with the tanning bulbs still on, and he was in severe pain. He has not sought medical attention for the sunburn, but described the sunburn as very deep, with discomfort and pain in his nerves and muscles. He has contacted sunfire industries, reported the incident on voice mail, but has not been successful at speaking with an associate of the firm. Model sf 25 deluxe canopy; s/n (b)(4): u=120v, 60 hz, p=2009w, i=18a, pf=0. 93, phase=single. Add'l info: i was able to obtain a copy of the sunfire 24 product manual from the firm's website. I confirmed that the tanning bed assembly steps consist of only four simple steps and none of the steps involves interaction with the tanning bed's timer. I reviewed the manuals section regarding the operation of the tanning bed timer, which i have abridged in part as follows: "lift the canopy, lie down on the bench (face up 0, lower the canopy as close to your body as possible. Turn the timer knob clockwise to the desired tanning session time to begin the tanning session. The lamps will turn on immediately. When the timer reaches "0" the lamps turn off. If you want to stop your session before time expires, turn the timer back to "0". Raise the canopy by pushing the outer edge of the canopy. " i located the responsible firm through the internet. On (b)(6) 2014 at 9:16 am, i contacted sunfire industries, inc. , and i spoke with (b)(4), president, who stated that he was aware of the anonymous complaint. His staff has attempted to reach the anonymous complainant, but has been unsuccessful. He explained that each bed goes through quality assurance checks before being shipped, which includes a test on the tanning bed timer. He promised to investigate the complaint, and submit a root cause analysis upon completion.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5036737
MDR Report Key3889030
Date Received2014-06-19
Date of Report2014-06-19
Date of Event2014-06-08
Date Added to Maude2014-06-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSUNFIRE 24 DELUXE
Generic NameSUNTAN BED
Product CodeLEJ
Date Received2014-06-19
Model NumberSF 24 DELUXE CANOPY
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerSUNFIRE INDUSTRIES, INC
Manufacturer Address4905 HWY 70 EAST NEW BERN NC 28562 US 28562


Patients

Patient NumberTreatmentOutcomeDate
10 2014-06-19

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