MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-18 for ARCTIC SUN 5000 50000000 manufactured by Medivance, Inc. ? 1725056.
[186175282]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[186175283]
It was found during evaluation that the right drain valve was leaking, the right angle power cord insulation was pulling loose from the restraining grommet exposing the inner wires, and there were 4 valves leaking on the fluid delivery line that will need new o rings.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01899 |
| MDR Report Key | 9850114 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-18 |
| Date of Report | 2020-04-03 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | MEDIVANCE, INC. |
| Manufacturer Street | 321 S TAYLOR AVE |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80027 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCTIC SUN 5000 |
| Generic Name | ARCTIC SUN DEVICE |
| Product Code | DWJ |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2020-02-13 |
| Model Number | 50000000 |
| Catalog Number | 50000000 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVANCE, INC. ? 1725056 |
| Manufacturer Address | 321 S TAYLOR AVE LOUISVILLE CO 80027 US 80027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |