MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-10-26 for COOL-CAP 401351-501 manufactured by Natus Medical Inc..
[58459709]
Natus complaint # (b)(4). Device return is anticipated. A follow-up report will be submitted when additional information is available. Device requested for investigation
Patient Sequence No: 1, Text Type: N, H10
[58459710]
Thirty one hours into patient treatment the a51 error (major water leak) prompted. There were no visible water leaks, and the water bag drained and water is in the cap and hoses. After restarting the system, there was no pump sound and no solenoid click. The process would not proceed beyond the fill screen. Patient was moved to another device in order to continue treatment. Customer reports interruption in treatment for 90 minutes. Device was requested to be returned to natus for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2016-00023 |
| MDR Report Key | 6059380 |
| Report Source | USER FACILITY |
| Date Received | 2016-10-26 |
| Date of Report | 2016-10-01 |
| Date of Event | 2016-10-01 |
| Date Mfgr Received | 2016-10-01 |
| Device Manufacturer Date | 2008-09-29 |
| Date Added to Maude | 2016-10-26 |
| 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 | MS. SVETLANA ROMANETS |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685170 |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOL-CAP |
| Generic Name | COOL CAP |
| Product Code | MXM |
| Date Received | 2016-10-26 |
| Model Number | 401351-501 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC. |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-26 |