MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-08-17 for OLYMPIC COOL-CAP SYSTEM 401701-501 manufactured by Natus Medical Incorporated.
[52381422]
As of 08/09/2016, device has not been returned to natus for evaluation. Device return is anticipated. A follow-up report will be submitted when additional information is available.
Patient Sequence No: 1, Text Type: N, H10
[52381423]
Customer stated that the patient developed pressure sores (fat necrosis caused by tissue damaged by the cold) on head and was admitted for further treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2016-00003 |
| MDR Report Key | 5884909 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-08-17 |
| Date of Report | 2016-07-19 |
| Date Mfgr Received | 2016-07-19 |
| Device Manufacturer Date | 2010-01-12 |
| Date Added to Maude | 2016-08-17 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SVETLANA ROMANETS |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685170 |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPIC COOL-CAP SYSTEM |
| Generic Name | COOL CAP |
| Product Code | MXM |
| Date Received | 2016-08-17 |
| Model Number | 401701-501 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-08-17 |