MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-08-05 for OLYMPIC COOL-CAP 401701-501 manufactured by Natus Medical Incorporated.
[116055506]
The engineering manager at the user facility conducted testing of the cool-cap system. In this testing it was determined that the water was correctly reaching set temperature and the screen would properly respond to commands. The most recent annual maintenance was conducted 8 months prior to the event, during which it was reported that the cooling unit's fans were blocked by accumulated dust. Natus technical service asked for additional details regarding the patient, the patient's condition, specifics of the reported temperature changes, and responsiveness of the touchscreen when the problem occurred, but no response was received. Natus technical service advised that they could not recommend any field repairs and the system must be returned to natus for repair. The system was not returned despite multiple requests sent by natus technical service.
Patient Sequence No: 1, Text Type: N, H10
[116055507]
It was reported to natus by an engineering manager at the user facility that the temperature of a cool-cap system was changing constantly and no alarm would indicate when these temperature changes would occur. The engineering manager stated that nurses at the user facility claimed that the cool-cap system would restart several times during treatment. The nurses claimed that after one of these restarts the cap could no longer be cooled, the water level in the cap was low, and a patient's temperature rose. There was no report of death, serious injury, or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00137 |
| MDR Report Key | 7750161 |
| Report Source | USER FACILITY |
| Date Received | 2018-08-05 |
| Date of Report | 2016-09-14 |
| Date Mfgr Received | 2016-09-14 |
| Date Added to Maude | 2018-08-05 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 |
| 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 | 2018-08-05 |
| Model Number | 401701-501 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-08-05 |