MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-02-07 for OLYMPIC COLL-CAP SYSTEM 60010 manufactured by Natus Medical Incorporated.
[3335233]
An infant was being treated for hypoxic ischemic encephalopathy with the cool-cap system when a pop sound came from the unit as well as a smoke smell during a rewarming process of a child. The unit shut down and the smoke smell was traced to filter below the water bag (power supply). There was no reported pt harm. There was no damage to the outlet or the power cable. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10510083]
The cause of this malfunction is most likely a failed power supply. The power supply on this sys is due to be replaced with a new power supply as part of a field corrective action ((b)(4)), but this failure occurred before the svc could be performed. The customer has been shipped a loaner device, and the affected unit has been returned to natus medical's (b)(4) facility for evaluation; and it is confirmed that this unit contains an older, excelsys power supply that is subject of the field corrective action. Natus anticipates no further reporting on this incident unless further investigation ito the failed sys shows a cause other than the excelsys power supply for the reported failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3018859-2013-00001 |
| MDR Report Key | 2975399 |
| Report Source | 05 |
| Date Received | 2013-02-07 |
| Date of Report | 2013-01-09 |
| Date of Event | 2013-01-08 |
| Date Mfgr Received | 2013-01-09 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2013-04-22 |
| 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 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 |
| Previous Use Code | 3 |
| Removal Correction Number | 3018859-05/25/12-002-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPIC COLL-CAP SYSTEM |
| Generic Name | COOLING CAP (INFANTS) |
| Product Code | MXM |
| Date Received | 2013-02-07 |
| Returned To Mfg | 2013-02-04 |
| Model Number | 60010 |
| Catalog Number | 60010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | SEATTLE WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-07 |