MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-05-21 for OLYMPIC COOL-CAP SYSTEM 60010 manufactured by Olympic Medical Incorporated.
[18055689]
An infant was being treated for hypoxic ischemic encephalopathy with a cool-cap system when the screen froze twice. It was reported that the device gave no alarms or messages either time the screen froze. The system was rebooted both times and treatment resumed. There was no reported pt harm. Device will be returned for eval. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18324417]
To be returned. The malfunction described in this event is the cause of an ongoing field correction recall (fda recall #z-0447-2013, natus capa (b)(4)). Natus is submitting a pma supplement for approval of a software upgrade that addresses this issue. There will be no follow-up to this report unless natus' review of this device shows a different failure/mode mechanism than described in the complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3018859-2013-00003 |
| MDR Report Key | 3127438 |
| Report Source | 05 |
| Date Received | 2013-05-21 |
| Date of Report | 2013-05-17 |
| Date of Event | 2013-04-26 |
| Device Manufacturer Date | 2009-02-26 |
| Date Added to Maude | 2013-07-30 |
| 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 | 2013-05-21 |
| Model Number | 60010 |
| Catalog Number | 60010 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPIC MEDICAL INCORPORATED |
| Manufacturer Address | SEATTLE WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-21 |