MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-01-09 for OLYMPIC COOL-CAP SYSTEM 401351-503 manufactured by Natus Medical Incorporated.
[64127841]
A system shut down or power interruption is caused by a complete loss of power or by an unintentional drop in voltage. Under these conditions the unit will prompt an error message to the user or restart automatically to continue treatment. The customer returned the cool cap system to (b)(4) for additional investigation, where it was confirmed by factory service that the power supply of the system was faulty, causing voltage drops during the cooling process. The power supply and the cooling module were replaced. After the parts were replaced, the system functioned as expected according to (b)(4) service procedures. The system was returned to the customer. This report is considered final.
Patient Sequence No: 1, Text Type: N, H10
[64127842]
(b)(4) was informed that during a patient treatment, the screen of a cool-cap system turned black and "came back on right away by itself" prompting the "power recovery" message. The system continued operating as expected and there was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2017-00009 |
| MDR Report Key | 6232189 |
| Report Source | USER FACILITY |
| Date Received | 2017-01-09 |
| Date of Report | 2016-05-19 |
| Date of Event | 2016-05-18 |
| Date Mfgr Received | 2015-09-17 |
| Date Added to Maude | 2017-01-09 |
| 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 | JEFFREY MANTKOWSKI |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685143 |
| 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 | OLYMPIC COOL-CAP SYSTEM |
| Generic Name | COOL CAP |
| Product Code | MXM |
| Date Received | 2017-01-09 |
| Model Number | 401351-503 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-09 |