MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-22 for OLYMPIC COOL-CAP 005094 manufactured by Natus Medical Incorporated.
[118536575]
It was reported that a cool-cap system had a permanent problem with the filling cycle involving the display of an error code e90. The complainant reported that steps were followed within the service manual (004204 rev d), and that during the filling cycle, the water bag was being consumed. There was no internal or external water leakage. The internal filter was washed several times. The filling valve was activated during the fill cycle and clicking could be heard. The problem reportedly occurred during the end of the fill cycle; the cap was filled and the pump was activated, but there appeared to be no water circulation and the e90 error message was being received. Natus technical service suggested that since there was no identifiable blockage to the flow of water, then the issue was likely a failing pump. There was no report of death, serious injury, delay in treatment, or environmental/safety concerns. The unit was returned for repairs. Natus factory service found that there was no continuous/smooth water flow within the cool-cap system due to a blockage within the cooling block and the flow switch/thermistor assembly. Flow rate was below the specification of 800 ccm (minimum). Both assemblies were replaced to isolate all of the piping system where the point of blockage occurred and the issue was fixed. The repaired cool-cap system passed natus functional test procedures and was returned to the complainant who did not report any further issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00148 |
| MDR Report Key | 7806590 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-08-22 |
| Date of Report | 2017-06-12 |
| Date Mfgr Received | 2017-06-12 |
| Date Added to Maude | 2018-08-22 |
| 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 | 2018-08-22 |
| Returned To Mfg | 2017-09-27 |
| Model Number | 005094 |
| Device Availability | R |
| 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 | 2018-08-22 |