N
Patient 1
RETURN OF THE COOL-CAP SYSTEM HAS BEEN REQUESTED BY NATUS TECHNICAL SERVICE, BUT THE SYSTEM HAS NOT BEEN RETURNED. AN INVESTIGATION IS IN PROGRESS AND A CAUSE HAS NOT BEEN DETERMINED.
MAUDE MDR 7774397
- MDR report key
- 7774397
- Report number
- 3018859-2018-00141
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-07-03
- Date received
- 2018-08-10
- 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
- JAMES FITZGERALD
- 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 | OLYMPIC COOL-CAP | COOL-CAP | NATUS MEDICAL INCORPORATED | MXM | 401701-501 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-08-10 | 0 | 1. O |
Event Narratives#
D
Patient 1
IT WAS REPORTED TO NATUS THAT AFTER PAUSING A PATIENT'S COOL-CAP TREATMENT TO TAKE AN ULTRASOUND, AN A51 WATER LEAK ERROR WAS EXPERIENCED WHEN ATTEMPTING TO RESUME TREATMENT. IT WAS NOT SPECIFIED BY THE COMPLAINANT WHERE THE WATER LEAKED FROM. IN ORDER TO TROUBLESHOOT THE ISSUE, THE WATER CAP WAS CHANGED AND THE SYSTEM WAS RESTARTED. UPON RESTARTING THE SYSTEM, THE ERROR MESSAGE CLEARED AND TREATMENT RESUMED. THE TROUBLESHOOTING PROCESS DELAYED THERAPY BY ABOUT ONE HOUR. AFTER TREATMENT WAS COMPLETED, THE SYSTEM WAS NO LONGER USED ON ACCOUNT OF THE ISSUE THAT HAD OCCURRED. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR ENVIRONMENTAL/SAFETY CONCERNS.