MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-11-03 for OLYMPIC COOL-CAP 401350-503 manufactured by Natus Medical Inc..
[91921483]
Natus technical service confirmed with the customer that the patient's rectal temperature was recorded at 36. 1? C. The user also confirmed the following - no kinks with any of the hoses, all of the connectors were fully snapped into place, and the fitting was fully seated. The customer reported that they tried to press "fill" again after reboot, but the attempt was unsuccessful. Technical support also advised the user to review the cool cap service guide. Follow up communication attempts with the customer were carried out on 17 oct 2017 and 30 oct 2017. These follow up attempts have been unsuccessful thus far.
Patient Sequence No: 1, Text Type: N, H10
[91921484]
The customer contacted natus medical to report that an "error 90," "fill error during setup," message occurred and was present from the start of the treatment. The patient was reported to have been connected to the cool cap for two hours. No death, serious injury, or environmental or safety concerns were reported. The customer reported that the unit never cooled and felt warm to the touch and that the water bag connected was 3/4 filled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2017-00870 |
| MDR Report Key | 7001152 |
| Report Source | USER FACILITY |
| Date Received | 2017-11-03 |
| Date of Report | 2017-10-06 |
| Date Mfgr Received | 2017-10-06 |
| Date Added to Maude | 2017-11-03 |
| 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 | JEFFREY MANTKOWSKI |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685143 |
| 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 | 2017-11-03 |
| Model Number | 401350-503 |
| 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 | 2017-11-03 |