N
Patient 1
SEVERAL ATTEMPTS HAVE BEEN MADE TO GET ADDITIONAL INFORMATION FROM THE CUSTOMER, BUT NO RESPONSE. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
MAUDE MDR 7153129
- MDR report key
- 7153129
- Report number
- 3018859-2017-01068
- Event key
- 0
- Event type
- 3
- Date received
- 2017-12-28
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 405
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MARC RIVAS
- Address
- 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US
- Phone
- 206-206-2062
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | COOL-CAP | COOL -CAP | NATUS MEDICAL INCORPORATED | MXM | 401701-501 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-12-28 | 0 |
Event Narratives#
D
Patient 1
NATUS MEDICAL RECEIVED A EMAILED COMPLAINT ON (B)(6) THAT THEIR COOL CAP RECIEVED A E90 FILING ERROR MESSAGE. IT WAS REPORTED THAT THERE WAS A PROBLEM WITH EITHER THE FILLING VALVE OR WATER PUMP. IT WAS REPORTED THAT THERE WAS NO DEATH OR SERIOUS INJURY THAT REQUIRED MEDICAL TREATMENT; NO DELAY IN TREATMENT; AND NO ENVIRONMENTAL OR SAFETY CONCERNS (E.G. SMOKE, OVERHEATING, ETC.).