MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-11-03 for OLYMPIC COOL-CAP 401352-503 manufactured by Natus Medical Inc..
[91921566]
During the call, natus technical service instructed the user to turn the unit off, to spike a new bag, and to reboot to the system "set up. " the user then reported that the cooling process was able to function without issue, and that the cool cap was no longer leaking. Follow up communication attempts with the customer were carried out on 18 oct 2017 and 30 oct 2017. These follow up attempts have been unsuccessful thus far.
Patient Sequence No: 1, Text Type: N, H10
[91921567]
The user reported that the unit was receiving an a51 alarm, "water leak error," during the treatment of a patient. The user also reported that the unit's cap was leaking and that the bed was wet near the area where the cap is located. Prior to the call, the user reported that they had changed the cap and that the bag was not full.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2017-00871 |
| MDR Report Key | 7001153 |
| Report Source | USER FACILITY |
| Date Received | 2017-11-03 |
| Date of Report | 2017-10-06 |
| Date Mfgr Received | 2017-10-06 |
| Date Added to Maude | 2017-11-03 |
| 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 | JEFFREY MANTKOWSKI |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685143 |
| 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 | MA |
| 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 | 2017-11-03 |
| Model Number | 401352-503 |
| 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 | 2017-11-03 |