MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-01-20 for COOL-CAP 401701-501 manufactured by Natus Medical Incorporated.
[65465350]
The customer has been asked to assist with the evaluation of this device. When additional information becomes available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[65465351]
The cool cap screen went blank causing an interruption 12 hours into the patient treatment. The customer was able to get the cool cap operating again, but had to start from the beginning for treatment. There has been no report of death or serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2017-00196 |
| MDR Report Key | 6268317 |
| Report Source | USER FACILITY |
| Date Received | 2017-01-20 |
| Date of Report | 2016-12-26 |
| Date of Event | 2016-12-26 |
| Date Mfgr Received | 2016-12-26 |
| Device Manufacturer Date | 2008-06-12 |
| Date Added to Maude | 2017-01-20 |
| 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 | JIM FITZGERALD |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685173 |
| 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 | 2017-01-20 |
| Returned To Mfg | 2017-12-20 |
| Model Number | 401701-501 |
| Operator | NURSE |
| 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 | 2017-01-20 |