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 2020-03-19 for ARCTICSUN 5000 50000000 manufactured by Medivance, Inc. ? 1725056.
[186333202]
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
[186333203]
It was reported that during evaluation of the arctic sun, the device required a test mixing pump to be installed in order to cool.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01911 |
| MDR Report Key | 9853125 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-19 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | ARCTICSUN 5000 |
| Generic Name | ARCTIC SUN DEVICE |
| Product Code | DWJ |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-01-16 |
| Model Number | 50000000 |
| Catalog Number | 50000000 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-19 |