MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-08-10 for OLYMPIC COOL-CAP 401701-501 manufactured by Natus Medical Incorporated.
[116864762]
Return of the cool-cap system has been requested by natus technical service, but the system has not been returned. An investigation is in progress and a cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
[116864763]
It was reported to natus that after pausing a patient's cool-cap treatment to take an ultrasound, an a51 water leak error was experienced when attempting to resume treatment. It was not specified by the complainant where the water leaked from. In order to troubleshoot the issue, the water cap was changed and the system was restarted. Upon restarting the system, the error message cleared and treatment resumed. The troubleshooting process delayed therapy by about one hour. After treatment was completed, the system was no longer used on account of the issue that had occurred. There was no report of death, serious injury, or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00141 |
| MDR Report Key | 7774397 |
| Report Source | USER FACILITY |
| Date Received | 2018-08-10 |
| Date of Report | 2018-07-12 |
| Date of Event | 2018-07-03 |
| Date Mfgr Received | 2019-02-26 |
| Date Added to Maude | 2018-08-10 |
| 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 |
| 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 | 2018-08-10 |
| Returned To Mfg | 2018-10-02 |
| Model Number | 401701-501 |
| 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 | 2018-08-10 |