MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-08-09 for OLYMPIC COOL-CAP 60010 manufactured by Natus Medical Inc.
[15174915]
Facility contacted natus medical incorporated to report the cool-cap malfunction. The device failed to perform as designed. The facility contacted natus medical incorporated to report that the cool cap monitor froze during treatment of a pt. The pt was then moved the pt to another cool cap unit and resumed treatment.
Patient Sequence No: 1, Text Type: D, B5
[15544177]
The reported device is part of an ongoing field corrective action. "the olympic cool-cap control module has experienced a frozen screen during use. When this occurs the on-screen info remains on display but the system is no longer providing cooling treatment to the pt. The visible clock in the upper right hand corner of the screen stops advancing. " natus medical incorporated contacted the facility to advise of the failure via (b)(4). The hosp facility did not respond to the corrective action notice delivered to them on 12/12/2012. Natus medical incorporated anticipates that there will be no further f/u to this report, as the issue is understood and is currently being corrected. If new info becomes available the f/u will be filed for this incident. No other info is available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3018859-2013-00006 |
| MDR Report Key | 3287715 |
| Report Source | 07 |
| Date Received | 2013-08-09 |
| Date of Report | 2013-07-28 |
| Date of Event | 2013-07-24 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2013-11-04 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 5900 FIRST AVE., SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685156 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-00447-2013 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPIC COOL-CAP |
| Generic Name | COOL-CAP |
| Product Code | MXM |
| Date Received | 2013-08-09 |
| Model Number | 60010 |
| Catalog Number | 60010 |
| Lot Number | NA |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-09 |