N
Patient 1
DEVICE RETURN IS ANTICIPATED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS AVAILABLE.
MAUDE MDR 5941082
- MDR report key
- 5941082
- Report number
- 3018859-2016-00014
- Event key
- 0
- Event type
- 3
- Date received
- 2016-09-09
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JEFFREY MANTKOWSKI
- 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 | 401351-505 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-09-09 | 0 | 1. O |
Event Narratives#
D
Patient 1
CUSTOMER CALLED NATUS ON (B)(6) 2016 STATING THAT COOL-CAP DEVICE SCREEN "SHUT DOWN" AND WOULD NOT RESPOND TO ANY ACTION. NATUS CONTACTED CUSTOMER FOR ADDITIONAL INFORMATION THAT WOULD ASSIST IN MAKING REPORTABILITY DECISION, AND ON (B)(6) 2016, CUSTOMER RESPONDED WITH A STATEMENT THAT DEVICE EXPERIENCED A SCREEN FREEZE WITH TIME CLOCK STOPPING AND NO ALARM WAS NOTED BY THE NURSE. CUSTOMER WAS ABLE TO GET THE SYSTEM STARTED AGAIN AFTER ABOUT 30 MINUTES AND THEY DID COMPLETE THE TREATMENT OF THE PATIENT. THERE WAS NO INJURY.
N
Patient 1
THE DEVICE WAS RETURNED AND EVALUATED. THE SYSTEM LOG INDICATES THE DEVICE WAS FUNCTIONING AS INTENDED AND WAS DELIVERING CONTINUOUS THERAPY TO THE PATIENT WHEN THE SCREEN WAS FROZEN. COOLING SESSIONS WITH A DATA CAPTURE SYSTEM WERE RAN FOR 720 HOURS WITHOUT HAVING ANY FREEZE EVENTS. THE WATCHDOG HARDWARE WAS TESTED AND DEMONSTRATED THAT THE WATCHDOG SYSTEM WAS FUNCTIONING CORRECTLY. A FUNCTIONAL TEST PROCEDURE WAS PERFORMED AND ALL ITEMS REGARDING THE REPORTED EVENT PASSED. THE SYSTEM ALSO REACTED APPROPRIATELY WHEN TEMPERATURE DROPPED BELOW THE LOWER CONTROL BAND AND INITIATED ALARM. THE AUDIBLE ALARM AND DISPLAY CIRCUITRY ARE INDEPENDENT OF EACH OTHER, SO IT'S PROBABLE THAT AN AUDIBLE ALARM DID OCCUR. (B)(4) WAS UNABLE TO CONFIRM THE FAILURE USING INFORMATION PROVIDED BY THE HOSPITAL, SESSION DATA ANALYSIS, TESTING, OR BY DIRECT OR INDIRECT OBSERVATION OF THE FAILURE. THE FAILURE WAS NOT DUPLICATED THROUGHOUT ALL TESTING. ADDITIONALLY, NO FUNCTIONAL OR PERFORMANCE PROBLEMS WERE FOUND WITH THE COOL-CAP UNIT, AS IT OPERATES FULLY WITHIN SPECIFICATION. ROOT CAUSE CANNOT BE DETERMINED. THE DEVICE MALFUNCTION WAS FOUND TO BE ISOLATED TO THE DISPLAY AND THE DEVICE CONTINUED TO DELIVER THE THERAPEUTIC COOLING FUNCTION, WITH EXCEPTION FOR THE TIME PERIODS WHEN THE SYSTEM WAS REBOOTING.
D
Patient 1
CUSTOMER CALLED (B)(4) ON (B)(6) 2016 STATING THAT COOL-CAP DEVICE SCREEN "SHUT DOWN" AND WOULD NOT RESPOND TO ANY ACTION. (B)(4) CONTACTED CUSTOMER FOR ADDITIONAL INFORMATION THAT WOULD ASSIST IN MAKING REPORTABILITY DECISION, AND ON (B)(6) 2016, CUSTOMER RESPONDED WITH A STATEMENT THAT DEVICE EXPERIENCED A SCREEN FREEZE WITH TIME CLOCK STOPPING AND NO ALARM WAS NOTED BY THE NURSE. CUSTOMER WAS ABLE TO GET THE SYSTEM STARTED AGAIN AFTER ABOUT 30 MINUTES AND THEY DID COMPLETE THE TREATMENT OF THE PATIENT. THERE WAS NO INJURY.