MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-12-06 for COOL-CAP 401701-501 manufactured by Natus Medical Incorporated.
[94835230]
The device has been requested from customer for further investigation. When additional information becomes available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[94835231]
Natus medical received a complaint on (b)(6) 2017 that their cool cap system locked up while in use. The user reported they attempted to enter the patient's gestational age, weight and all the needed information and the device "starts thinking", but the screen does not progress. It was reported that there was a delay in treatment (no other specifics were noted within the service request); however, no death or serious injury that required medical treatment, and no environmental or safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2017-00992 |
| MDR Report Key | 7088689 |
| Report Source | USER FACILITY |
| Date Received | 2017-12-06 |
| Date of Report | 2017-11-06 |
| Date of Event | 2017-07-11 |
| Date Mfgr Received | 2017-11-06 |
| Device Manufacturer Date | 2010-12-20 |
| Date Added to Maude | 2017-12-06 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KYLE HORTON |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2068343921 |
| 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 | 2017-12-06 |
| Model Number | 401701-501 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-12-06 |