MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-08-17 for COOL-CAP 401351-501 manufactured by Natus Medical Incorporated.
[83130348]
Natus medical has launched investigation. The device has been requested from customer. A supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[83130349]
Natus medical received a complaint on (b)(6) that their cool cap device recieved a error e90. The customer reported no death, patient harm or serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2017-00590 |
| MDR Report Key | 6802602 |
| Report Source | USER FACILITY |
| Date Received | 2017-08-17 |
| Date of Report | 2017-07-18 |
| Date Mfgr Received | 2018-08-10 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2017-08-17 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JIM FITZGERALD |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 5613065818 |
| 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 | 2017-08-17 |
| Returned To Mfg | 2018-07-30 |
| Model Number | 401351-501 |
| Device Availability | R |
| Device Age | DA |
| 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 | 1. Other | 2017-08-17 |