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 ARCTIC SUN 5000 50000000E manufactured by Medivance, Inc. ? 1725056.
[186335961]
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
[186335962]
It was reported that there was an alert 02 while initiating therapy on the arctic sun device. The flow rate was 0lpm, the inlet pressure was -7. 1 psi, the circulation pump was 51% and cv was 0. The pump hours were 762 and system hours were 818. They disconnected the pads and placed the device in manual mode. The flow rate was 0lpm, the inlet was -7. 1 psi and the circulation pump was 46%. Ms&s advised to send device to biomed. Per follow up on (b)(6) 2020, the charge nurse (b)(6) stated they swapped devices to complete therapy and the device was kept in service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01948 |
| MDR Report Key | 9853821 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date Mfgr Received | 2020-02-28 |
| 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 | 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 | 2020-03-19 |
| Model Number | 50000000E |
| Catalog Number | 50000000E |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 |