N
Patient 1
NATUS COMPLAINT # (B)(4). DEVICE RETURN IS ANTICIPATED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS AVAILABLE. DEVICE REQUESTED FOR INVESTIGATION
MAUDE MDR 6059380
- MDR report key
- 6059380
- Report number
- 3018859-2016-00023
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-10-01
- Date received
- 2016-10-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. SVETLANA ROMANETS
- 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 INC. | MXM | 401351-501 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-10-26 | 0 | 1. O |
Event Narratives#
D
Patient 1
THIRTY ONE HOURS INTO PATIENT TREATMENT THE A51 ERROR (MAJOR WATER LEAK) PROMPTED. THERE WERE NO VISIBLE WATER LEAKS, AND THE WATER BAG DRAINED AND WATER IS IN THE CAP AND HOSES. AFTER RESTARTING THE SYSTEM, THERE WAS NO PUMP SOUND AND NO SOLENOID CLICK. THE PROCESS WOULD NOT PROCEED BEYOND THE FILL SCREEN. PATIENT WAS MOVED TO ANOTHER DEVICE IN ORDER TO CONTINUE TREATMENT. CUSTOMER REPORTS INTERRUPTION IN TREATMENT FOR 90 MINUTES. DEVICE WAS REQUESTED TO BE RETURNED TO NATUS FOR INVESTIGATION.