MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2020-03-17 for ARCTIC SUN? TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE NELLCOR 735-02 manufactured by Medivance, Inc. ? 1725056.
[186020944]
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
[186020945]
It was reported that an arctic sun device displayed an alert 50 and alarm 15. The biomed checked the cable and it was frayed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01851 |
| MDR Report Key | 9841621 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| 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? TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE NELLCOR |
| Generic Name | TEMP IN CABLE |
| Product Code | DWJ |
| Date Received | 2020-03-17 |
| Catalog Number | 735-02 |
| 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 | 2020-03-17 |