N
Patient 1
DEVICE RETURN AND EVALUATION ANTICIPATED. NATUS MEDICAL CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
MAUDE MDR 5756716
- MDR report key
- 5756716
- Report number
- 3018859-2016-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-06-03
- Date received
- 2016-06-28
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. 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 | OLYMPIC COOL-CAP SYSTEM | COOL CAP | NATUS MEDICAL INCORPORATED | MXM | 401350-503 | N/A | N/A | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-06-28 | 0 | 1. O |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT A COOL-CAP SYSTEM FROZE DURING A COOLING TREATMENT. THE TREATMENT WAS STARTED AT 23:00 ON THE EVENING OF (B)(6) 2016. REPORTEDLY THE STAFF NOTICED IT WHEN PERFORMING THEIR ROUNDS; THE REPORTER NOTED THAT SYSTEM PROBABLY FROZE WITHIN THE LAST HOUR PRIOR TO CALLING NATUS TECHNICAL SUPPORT. THE TECHNICAL SUPPORT REPRESENTATIVE INQUIRED IF THE SYSTEM CLOCK WAS STILL ADVANCING. THE CALLER REPORTED IT WAS NOT. THE TECHNICAL SUPPORT REPRESENTATIVE SUGGESTED POWERING DOWN THE COOL-CAP SYSTEM AND THEN TURNING IT BACK ON. REPORTEDLY UPON BOOT UP, THE COOL-CAP SYSTEM PROMPTED IF USER WOULD LIKE TO CONTINUE WITH THE CURRENT COOLING TREATMENT; THE CALLER CHOSE TO CONTINUE WITH CURRENT TREATMENT. THE PATIENT'S RECTAL TEMP WAS 33.8C AT THE TIME OF THE REPORT AND THE COOL-CAP TEMPERATURE WAS SET AT 12C.
N
Patient 1
DEVICE WAS RECEIVED ON 07/19/2016 AND EVALUATION COMPLETE ON 08/03/2016. IT WAS CONFIRMED THAT REPORTED COOL CAP SYSTEM EXPERIENCED A FAILURE IN WHICH THE USER INTERFACE AND LOGGING FUNCTION FROZE, BUT THE SESSION DATA IMPLIES THAT THE COOLING UNIT STAYED ONLINE AND CONTINUED TO FUNCTION PROPERLY SINCE THE RECTAL AND SCALP TEMPERATURES WERE BOTH LOWER AFTER THE UNIT WAS RESTARTED THAN WHEN THE FAILURE OCCURED APPROXIMATELY FOUR HOURS EARLIER. FAILURE OCCURED BEFORE 8H (RECTAL TEMP=34.7 C) AND SYSTEM WAS RESTARTED (POWER RECOVERY EVENT) BY USER AT APPROXIMATELY 12H (RECTAL TEMPERATURE = 33.83 C) ROOT CAUSE CAN NOT BE DETERMINED AT THIS TIME, BECAUSE NATUS MEDICAL (MANUFACTURER) WAS UNABLE TO DUPLICATE REPORTED FAILURE. INVESTIGATION OF THIS ISSUE WILL BE CONTINUED IN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION AND TO DETERMINE THE ROOT CAUSE OF THE ISSUE. IF ADDITIONAL INFORMATION WILL BECOME AVAILABLE, FOLLOW-UP REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56