MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-07-12 for OLYMPIC COOL-CAP SYSTEM 60010 manufactured by Natus Medical Inc.
[3594161]
A nurse reported that the screen display froze when they were getting ready to treat an infant. The infant was placed on a secondary cool-cap system for treatment. The biomed was unable to duplicate the issue after rebooting the system. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10964241]
The malfunction described in this event appears to be the "screen freeze" issue that is the cause of an ongoing field corrective action (fda recall #z-0447-2013, natus capa (b)(4)). Natus has submitted a pma supplement for approval of a software upgrade that addresses this issue. Natus anticipates that there will be no follow-up to this report. The system was rebooted and is functioning properly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3018859-2013-00004 |
| MDR Report Key | 3229540 |
| Report Source | 05 |
| Date Received | 2013-07-12 |
| Date of Report | 2013-07-10 |
| Date of Event | 2013-06-17 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2013-10-03 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVE HESLER |
| 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-0447-2013 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPIC COOL-CAP SYSTEM |
| Generic Name | COOLING CAP (INFANTS) |
| Product Code | MXM |
| Date Received | 2013-07-12 |
| Model Number | 60010 |
| Catalog Number | 60010 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC |
| Manufacturer Address | SEATTLE WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-12 |