N
Patient 1
INVESTIGATION IS IN PROCESS PENDING THE ANALYSIS OF DATA LOGS. (B)(4).
MAUDE MDR 8218869
- MDR report key
- 8218869
- Report number
- 3009156722-2018-00011
- Event key
- 0
- Event type
- 3
- Date received
- 2019-01-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 401
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. SERENA CHEN
- Address
- 1203 NANHUAN AVENUE GUANGMING DISTRICT SHENZHEN, GUANGDONG 51810 CH
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BENEVISION CENTRAL MONITORING SYSTEM | BENEVISION | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | MSX | BENEVISION CENTRAL MONITORING SYSTEM | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-01-04 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT A PATIENT WITH A PACEMAKER WAS BEING MONITORED ON A BENEVISION TM80 TELEMETRY TRANSMITTER. THE PACER ENHANCEMENT WAS TURNED ON BUT THERE WERE NO PACER SPIKES SEEN ON THE MONITOR. NO PATIENT INJURY WAS REPORTED.