MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-05 for OLYMPIC COOL-CAP 401701-501 manufactured by Natus Medical Incorporated.
[116049128]
Natus technical service made multiple attempts to request additional information regarding the patient and their condition, but these requests were not answered. A technician sent to the user facility verified that the correct mains voltage was reaching the power supply, but the system would not turn on and the power supply fan was not spinning. The user facility was provided with a replacement power supply. It was reported that once the replacement power supply was installed, the system began working correctly and was put back into service.
Patient Sequence No: 1, Text Type: N, H10
[116049129]
It was reported to natus by a distributor that a cool-cap system powered down during treatment and treatment was interrupted. Once powered down, the system would no longer turn on. There was no report of death, serious injury, or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3018859-2018-00138 |
MDR Report Key | 7750206 |
Report Source | COMPANY REPRESENTATIVE |
Date Received | 2018-08-05 |
Date of Report | 2016-10-27 |
Date Mfgr Received | 2016-10-27 |
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 |
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 | RP |
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 | N |
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 |