MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-13 for OLYMPIC COOL-CAP 005094 manufactured by Natus Medical Incorporated.
[120256986]
Natus technical service has requested return of the system. Natus technical service has sent questions to the complainant regarding the details of the event and the patient involved in the event. A response to these requests has not been received.
Patient Sequence No: 1, Text Type: N, H10
[120256987]
It was reported that a cool-cap system's cap temperature was high as compared to the set temperature. A patient was being treated with the system when the event occurred, and the patient was moved to another cool-cap system. There was no death, serious injury, delay in treatment, or environmental/safety concerns. A service technician who reported the event performed a heat load test as described in the cool-cap service manual and functional test procedure. The technician claimed that the test demonstrated that the internal thermistors were faulty. However, based on photos provided by the technician, natus factory service noted that the heat load test was performed incorrectly. Natus factory service stated that testing the functionality of the cooling modules would also require performing a different test.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00150 |
| MDR Report Key | 7873604 |
| Date Received | 2018-09-13 |
| Date of Report | 2018-08-14 |
| Date Mfgr Received | 2018-10-23 |
| Device Manufacturer Date | 2011-03-25 |
| Date Added to Maude | 2018-09-13 |
| 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 |
| 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 | 2018-09-13 |
| Returned To Mfg | 2018-10-23 |
| Model Number | 005094 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-09-13 |