MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-02-16 for OLYMPIC COOL-CAP 401701-501 manufactured by Natus Medical Inc..
[100511945]
The asc representative indicated that there was no fault with the unit and required assistance on how to move forward with the situation. Technical service advised that if there was no issue confirmed, that the unit can be returned to the customer.
Patient Sequence No: 1, Text Type: N, H10
[100511946]
The event involves a cool-cap unit with a water leak. It was reported that the issue did not involve a death or serious injury that required treatment, a delay in treatment, and an environmental or safety concerns. A representative from an authorized service center (asc), paragon, contacted natus technical service concerning a cool cap system. The customer is alleging that there is a water leak and has reported to have spent approximately 60 hours testing the water circulation. The customer reported that, when filling the bag with water, the cap of the unit was filling well. The remaining water in the bag was leaking onto the floor of the main unit after completely filling the cap. The customer requested that the asc attempt this process to confirm the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00098 |
| MDR Report Key | 7277196 |
| Report Source | USER FACILITY |
| Date Received | 2018-02-16 |
| Date of Report | 2018-01-17 |
| Date Mfgr Received | 2018-01-17 |
| Date Added to Maude | 2018-02-16 |
| 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 | ANA SZUCS |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685133 |
| 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 | 2018-02-16 |
| Model Number | 401701-501 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC. |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-16 |