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 2020-03-18 for ARCTICSUN GEL PADS 318-02-02 manufactured by Medivance, Inc. ? 1725056.
[186177277]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[186177278]
It was reported that an arctic sun device displayed a flow rate of 0. 9lpm. The pads were disconnected and reconnected, and the flow rate rose to 1. 2lpm. The patient's target temperature was 37c and the patient's temperature was 36. 8c. Per follow up, the patient was able to complete therapy with the same set of pads. Those pads were discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01902 |
| MDR Report Key | 9850307 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-02-24 |
| 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 |
| 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 GEL PADS |
| Generic Name | GEL PADS |
| Product Code | DWJ |
| Date Received | 2020-03-18 |
| Catalog Number | 318-02-02 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 |