MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-05-28 for ERGOLINE AMBITION 300 NA manufactured by Jk Products & Services.
[5922017]
Injury to fingers when they were allegedly inserted into the foot fan.
Patient Sequence No: 1, Text Type: D, B5
[13418598]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2311923-2015-00001 |
| MDR Report Key | 4808790 |
| Report Source | 06 |
| Date Received | 2015-05-28 |
| Date of Report | 2015-04-29 |
| Date of Event | 2015-04-24 |
| Date Mfgr Received | 2015-04-27 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2015-06-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHEAL CRAIG |
| Manufacturer Street | 1 WALTER KRATZ DR. |
| Manufacturer City | JONESBORO AR 72401 |
| Manufacturer Country | US |
| Manufacturer Postal | 72401 |
| Manufacturer Phone | 8709351130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ERGOLINE |
| Generic Name | SUNTAN BED |
| Product Code | LEJ |
| Date Received | 2015-05-28 |
| Model Number | AMBITION 300 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JK PRODUCTS & SERVICES |
| Manufacturer Address | JONESBORO AR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-28 |