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 401701-501 manufactured by Natus Medical Incorporated.
[64128857]
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 restarting automatically and continuing treatment. The cool-cap system was returned to natus 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 was replaced and the system functioned as expected according to natus service procedures.. The system was returned to the customer. This report is considered final.
Patient Sequence No: 1, Text Type: N, H10
[64128858]
Natus received a report stating their cool-cap system "shut off" twice while treating a patient: the first time the unit was in use for less than 12 hours, and the second time the unit was in use for less than 24 hours
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2017-00008 |
| MDR Report Key | 6232187 |
| Report Source | USER FACILITY |
| Date Received | 2017-01-09 |
| Date of Report | 2016-09-17 |
| 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 | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 |
| Returned To Mfg | 2015-04-01 |
| Model Number | 401701-501 |
| Device Availability | R |
| 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 | 2017-01-09 |