MAUDE Adverse Event Report: JK PRODUCTS & SERVICES ERGOLINE; SUNTAN BED

Model Number AMBITION 300

Device Problems Inadequate or Insufficient Training (1643); Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 04/24/2015

Event Type  Injury  

Event Description

Injury to fingers when they were allegedly inserted into the foot fan.

Manufacturer Narrative

This tanning appliance model has been tested where applicable and found to be in compliance with underwriters laboratory standards ul (b)(4) luminaries, ul (b)(4) portable sun/heat lamps, and ul (b)(4) commercial refrigerators and freezers.This testing resulted in the listing and approval to be marked with the intertek testing services (etl) certification (report number (b)(4)).This incident has been investigated to the fullest extent possible given the information provided and only limited access to said tanning appliance by the salon, due to the anticipation of a liability claim being filed by the injured customer.Our findings show that as produced the fan grill provides proper protection from inadvertent contact with the fan.The lack of evidence i.E.Blood and inability to locate the missing appendages, raises question as to the exact account of how the incident occurred.Our investigation concludes that given the standards used to test and evaluate our product, plus the small openings of the fan grill and proximity of the fan blades to the grill, combined with the fact that the fan is located at the foot end of the bed and being the furthest most point from the user controls including the start/stop button.Therefore we are confident the incident was not caused by the device, and conclude the incident was a result of improper use and/or modification of the fan from its as produced state.

• Brand Name: ERGOLINE
• Type of Device: SUNTAN BED
• Manufacturer (Section D): JK PRODUCTS & SERVICES; jonesboro AR
• Manufacturer Contact: micheal craig ; 1 walter kratz dr.; jonesboro, AR 72401 ; 8709351130
• MDR Report Key: 4808790
• MDR Text Key: 5922017
• Report Number: 2311923-2015-00001
• Device Sequence Number: 1
• Product Code: LEJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: AMBITION 300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 86