MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-07-19 for OLYMPIC COOL-CAP SYSTEM 60010 NA manufactured by Natus Medical Inc..
[3610982]
Hospital contacted natus to report cooling cap (product # 60010) malfunction. Device failed to perform to specification. Device monitor screen froze during use. Hospital contact informed natus, that they were aware of the freezing issue prior to treatment. No other details provided by the facility.
Patient Sequence No: 1, Text Type: D, B5
[10963976]
Reported device is part of an ongoing field corrective action ((b)(4)). "the olympic cool-cap's control module has experienced a frozen screen during use. When this occurs, the on-screen information remains on display, but the system is no longer providing cooling treatment to the infants. The visible clock displayed at the upper right hand corner of the screen stops advancing. " natus contacted hospital facility to advice of failure via fedex mail. Hospital facility did not respond to the corrective action notice delivered to them on 12/12/2012. Natus anticipated that there will be no follow-up to this report, as the issue is understood, and currently being corrected. If the new information becomes available, the follow-up will be filed for this incident. No other information is available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3018859-2013-00005 |
| MDR Report Key | 3245397 |
| Report Source | 07 |
| Date Received | 2013-07-19 |
| Date of Report | 2013-07-18 |
| Date Added to Maude | 2013-10-17 |
| 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 | 0 |
| 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 | 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 (NEWBORN CARE) |
| Product Code | MXM |
| Date Received | 2013-07-19 |
| Model Number | 60010 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC. |
| Manufacturer Address | SEATTLE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-19 |