MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-06-01 for OLYMPIC COOL-CAP manufactured by Natus Medical Inc..
[110365242]
The asc used certified calibrated instruments, and it was determined that the temperature sensors work correctly. At the same time, a flow thermometer was used to verify the temperature of the water flow. The asc found that the machine is not able to get to the temperature of 15? C. The asc performed testing per natus service manual instructions. The asc believes the cooling unit has failed and has contacted technical service for repair options. An email requesting more information was sent to the customer on 5/25/2018, and the customer has not responded.
Patient Sequence No: 1, Text Type: N, H10
[110365243]
An end user reported to the authorized service center (asc) that the cool cap temperature readings were suspected to be incorrect. There has been no report of a death or serious injury that required treatment, a delay in treatment, and an environmental or safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00131 |
| MDR Report Key | 7562963 |
| Report Source | USER FACILITY |
| Date Received | 2018-06-01 |
| Date of Report | 2018-05-03 |
| Date Mfgr Received | 2018-05-03 |
| Date Added to Maude | 2018-06-01 |
| 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 | JIM FITZGERALD |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685173 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPIC COOL-CAP |
| Generic Name | COOL-CAP |
| Product Code | MXM |
| Date Received | 2018-06-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC. |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-01 |