MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-07-13 for OLYMPIC COOL-CAP manufactured by Natus Medical Incorporated.
[114430873]
Natus technical service provided ordering information for a replacement main hose assembly which includes the hose fittings described in the complaint. The ordering information was passed on by the distributor to the user facility. Natus technical service made multiple attempts to obtain the serial number of the cool-cap system, but no response was received. An order was not received for a replacement main hose assembly and no further communication regarding the complaint was received.
Patient Sequence No: 1, Text Type: N, H10
[114430874]
Natus received a report from a (b)(4) distributor that a hose fitting had broken on the main hose assembly of a cool-cap system. A photo was provided of the damaged fitting. No patient was involved and the issue was identified prior to initiating any treatment. There was no report of death, serious injury, delay in treatment, or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00133 |
| MDR Report Key | 7688210 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-07-13 |
| Date of Report | 2017-04-19 |
| Date Mfgr Received | 2017-04-19 |
| Date Added to Maude | 2018-07-13 |
| 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 |
| Remedial Action | OT |
| 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 | 2018-07-13 |
| 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 | 2018-07-13 |