MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-01-10 for OLYMPIC COOL-CAP 401352-01 manufactured by Natus Medical Inc..
[96966653]
The customer reported that the patient was placed into a backup cooling device. The customer has not reported the alarm identifier, the patient's rectal temperature or the specific hours of treatment. Follow up communication attempts with the customer were carried out on 14 dec 2017 and 09 jan 2018. These follow up attempts have been unsuccessful in obtaining additional information thus far. The customer has since placed an order for device service and a loaner cool cap unit.
Patient Sequence No: 1, Text Type: N, H10
[96966654]
A customer called natus technical service to report that, prior to the call, the cool cap device was indicating that there was a major water leak and the patient had been cooling for two days. The customer confirmed that there was no apparent water leakage, but the main hose (red) was reported not to be completely connected. The customer also reported a full water bag. After properly connecting the main hose, the issue still persisted, and the customer was unable to clear the error. The cool cap was rebooted, and during the reboot process, the customer reported that the system would not fill and that the resume selection was "grayed out. " the customer attempted to replace/spike a new bag. The customer also reported that the area was loud, which would not allow them to verify if the pump was active or if the system made any clicking noises. No death, serious injury, delay in care or environmental/safety concerns have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00030 |
| MDR Report Key | 7179627 |
| Report Source | USER FACILITY |
| Date Received | 2018-01-10 |
| Date of Report | 2017-12-13 |
| Date Mfgr Received | 2018-02-07 |
| Device Manufacturer Date | 2008-09-30 |
| Date Added to Maude | 2018-01-10 |
| 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 | JAMES 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 | RL |
| 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 | 2018-01-10 |
| Returned To Mfg | 2018-02-07 |
| Model Number | 401352-01 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-01-10 |