MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-03 for OLYMPIC COOL-CAP SYSTEM 60010 manufactured by Natus Medical Incorporated.
[2218439]
Infant being treated for (b)(6) with the olympic cool-cap system. Approx 14. 5 hours into treatment, a burning smell was noted. The infant was moved to a different isolette because the smell was thought to have been coming from the isolette. Approx 9. 5 hours later a strong burning smell was noted. A short while later three popping sound were heard and the device shut down. The infant was transported to another facility to complete the treatment.
Patient Sequence No: 1, Text Type: D, B5
[9370631]
The cause of the device malfunction was a failed power supply. Four components within the power supply failed (a 4-pin connector, a power transistor, a resistor and diode). The power supply was purchased from (b)(4). This power supply issue is being investigated under (b)(4) that was opened by (b)(6) in (b)(6) 2010. The customer's device is being repaired and the failed power supply is being replaced with one that was purchased from (b)(6). This alternate power supply was approved by the fda for use with the cool-cap device on (b)(6) 2010 under pma supplement (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3018859-2011-00007 |
| MDR Report Key | 2313555 |
| Report Source | 05,06 |
| Date Received | 2011-10-03 |
| Date of Report | 2011-10-03 |
| Date of Event | 2011-09-10 |
| Date Mfgr Received | 2011-09-12 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2012-06-29 |
| 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 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPIC COOL-CAP SYSTEM |
| Generic Name | COOLING CAP (INFANTS) |
| Product Code | MXM |
| Date Received | 2011-10-03 |
| Returned To Mfg | 2011-09-25 |
| Model Number | 60010 |
| Catalog Number | 60010 |
| Lot Number | NA |
| ID Number | VERSION 2.0 SOFTWARE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-03 |