MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-07-31 for OLYMPIC COOL-CAP DM401352-503 manufactured by Natus Medical Incorporated.
[115650261]
Natus technical service followed up with a biomedical technician (biomed) at the user facility to obtain further details concerning the leaking system. The biomed confirmed that there was a cracked o-ring on the out line connector of the main hose. A replacement main hose assembly was sent to the user facility, and the biomed confirmed that the cool-cap system was working well with the replacement main hose assembly installed. The main hose assembly involved in the complaint was returned to natus and evaluated by natus factory service. The hose assembly was installed on a cool-cap troubleshooting fixture and water leaked at the hose assembly's connector mated to the "main hose out" of the cool-cap base.
Patient Sequence No: 1, Text Type: N, H10
[115650262]
It was reported to natus that a cool-cap system developed a slow water leak at the water fittings on the back of the cooling tower at the beginning of treatment. The complainant stated that they continued to use the system for 36 hours before transitioning the patient to a second cool-cap loaner system which was being used at the time. There were no alarms that prompted or any problems reported during the treatment. There was no report of death, serious injury, or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00134 |
| MDR Report Key | 7737021 |
| Report Source | USER FACILITY |
| Date Received | 2018-07-31 |
| Date of Report | 2016-09-06 |
| Date Mfgr Received | 2016-09-06 |
| Date Added to Maude | 2018-07-31 |
| 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 | RL |
| 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 | 2018-07-31 |
| Model Number | DM401352-503 |
| Device Availability | N |
| 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 | 2018-07-31 |