MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-09-05 for OLYMPIC COOL-CAP SYSTEM 60010 manufactured by Natus Medical Incorporated.
[2894016]
(b)(6) being treated for neonatal hypoxic-ischemic encephalopathy with the olympic cool-cap system. Approximately 29. 5 hours into treatment, three popping sounds were heard and the control module turned off. The infant was moved to a cooling blanket while an alternate cool-cap system was brought in from another facility to complete the treatment. The infant's temperature was maintained in the target range throughout the 72-hour treatment. There was no patient or user injury.
Patient Sequence No: 1, Text Type: D, B5
[10042872]
The cause of the device malfunction was a failed power supply. The power supply was scheduled to be replaced on-site as part of a field corrective action ((b)(4)) but the failure occurred before the correction could be made. The power supply will now be replaced by (b)(4) and the repaired device returned to the customer.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 3018859-2012-00004 |
MDR Report Key | 2742082 |
Report Source | 05,06 |
Date Received | 2012-09-05 |
Date of Report | 2012-09-05 |
Date of Event | 2012-08-10 |
Date Mfgr Received | 2012-08-10 |
Device Manufacturer Date | 2008-03-01 |
Date Added to Maude | 2012-12-18 |
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 | 2012-09-05 |
Returned To Mfg | 2012-08-31 |
Model Number | 60010 |
Catalog Number | 60010 |
Lot Number | NOT APPLICABLE |
ID Number | VERSION 2.0 SOFTWR |
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 | 2012-09-05 |