MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-10-03 for OLYMPIC COOL-CAP SYSTEM 60010 manufactured by Natus Medical Inc..
[3069091]
Infant being treated for neonatal hypoxic-ischemic encephalopathy with the olympic cool-cap system. The user noted a smell similar to an electrical device being overheated but the device continued to function normally. Approximately 18 hours into treatment, a click sound was heard and the control module turned off. The issue was not resolved by plugging the device into a different electrical outlet. The infant's 72-hour treatment was completed using a cool-cap system in a nearby hospital. There was no patient or user injury.
Patient Sequence No: 1, Text Type: D, B5
[10212510]
Serial #: (b)(4). The cause of the device malfunction was most likely a failed power supply. The power supply was scheduled to be replaced on-site as part of a field corrective action (correction report 3018859-05/25/12-002-c; fda recall #z-1843-2012; natus capa # (b)(4)) but the failure occurred before the correction could be made. The power supply will now be replaced by natus-(b)(4) and the repaired device returned to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3018859-2012-00005 |
| MDR Report Key | 2776638 |
| Report Source | 01,08 |
| Date Received | 2012-10-03 |
| Date of Report | 2012-10-03 |
| Date of Event | 2012-09-05 |
| Date Mfgr Received | 2012-09-05 |
| Device Manufacturer Date | 2009-04-01 |
| Date Added to Maude | 2013-01-18 |
| 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., SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685170 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 3018859-05/25/12-002-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPIC COOL-CAP SYSTEM |
| Generic Name | COOLING CAP (INFANTS) |
| Product Code | MXM |
| Date Received | 2012-10-03 |
| Model Number | 60010 |
| Catalog Number | 60010 |
| Lot Number | NA |
| ID Number | VERSION 2.0 SOFTWARE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2012-10-03 |