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..
[100510959]
The cool cap is currently in the process of returning to the asc for further evaluation.
Patient Sequence No: 1, Text Type: N, H10
[100510960]
The event involves a cool-cap unit with an e90 filling error. There has been no report of 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) contacted natus technical service concerning a cool cap with a filling error (e90). The customer reported that the pump had some faults and that the internal filter was cleaned prior to testing, but the filling error message was still present.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00102 |
| MDR Report Key | 7277192 |
| Report Source | USER FACILITY |
| Date Received | 2018-02-16 |
| Date of Report | 2018-01-18 |
| Date Mfgr Received | 2018-01-18 |
| 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 |