N
Patient 1
THE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(4).
MAUDE MDR 5664343
- MDR report key
- 5664343
- Report number
- 1721752-2016-00005
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-04-26
- Date received
- 2016-05-18
- 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
- JOAQUIN KURZ
- Address
- 33 TECHNOLOGY DRIVE IRVINE CA 92618 US
- Phone
- 949-949-9497
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-05-18 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THE USER CANNOT INCREASE FLOW RATE WHILE DELIVERING RF ENERGY DURING ABLATION PROCEDURE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. (B)(4) TAKES CONSERVATIVE APPROACH TO REPORT THIS ISSUE.
N
Patient 1
(B)(4). IT WAS REPORTED THAT CLIENT CANNOT INCREASE FLOW RATE WHILE DELIVERING RF ENERGY. REPAIR FOLLOW UP WAS PERFORMED AND IT WAS INFORMED THAT PUMP WILL NOT BE SENT FOR TESTING AS IT IS WORKING CORRECTLY. SERVICE WAS DECLINED. THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. COMPLAINT WAS UNABLE TO CONFIRM.