MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-01 for OLYMPIC COOL-CAP SYSTEM 60010 manufactured by Natus Medical Incorporated.
[21981796]
Infant being treated for neonatal hypoxic-ischemic encephalopathy with the olympic cool-cap system. Approx 44 hours into treatment, the device exhibited a shutdown characterized by a frozen display screen. Rectal temperature was 35. 5c when issue was discovered. Device was rebooted and treatment continued without further incident. There was no pt injury.
Patient Sequence No: 1, Text Type: D, B5
[22131485]
Natus medical incorporated will submit a follow-up report to fda when the device investigation / testing is completed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3018859-2012-00001 |
| MDR Report Key | 2449533 |
| Report Source | 05,06 |
| Date Received | 2012-02-01 |
| Date of Report | 2012-02-01 |
| Date of Event | 2012-01-04 |
| Date Mfgr Received | 2012-01-04 |
| Device Manufacturer Date | 2008-07-01 |
| Date Added to Maude | 2012-08-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 5900 FIRST AVE. S. |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685170 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPIC COOL-CAP SYSTEM |
| Generic Name | COOLING CAP (INFANTS) |
| Product Code | MXM |
| Date Received | 2012-02-01 |
| Returned To Mfg | 2012-01-13 |
| Model Number | 60010 |
| Catalog Number | 60010 |
| Lot Number | NOT APPLICABLE |
| ID Number | VERSION 2.0 SOFTWARE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | SEATTLE WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-01 |