MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-01-04 for BENEVISION CENTRAL MONITORING SYSTEM manufactured by Shenzhen Mindray Bio-medical Electronics Co., Ltd.
[132788935]
Investigation is in process pending the analysis of data logs. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[132788936]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009156722-2018-00011 |
| MDR Report Key | 8218869 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-04 |
| Date of Report | 2019-05-24 |
| Date Facility Aware | 2018-12-05 |
| Report Date | 2019-01-04 |
| Date Reported to Mfgr | 2019-01-04 |
| Date Mfgr Received | 2019-05-24 |
| Date Added to Maude | 2019-01-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SERENA CHEN |
| Manufacturer Street | 1203 NANHUAN AVENUE GUANGMING DISTRICT |
| Manufacturer City | SHENZHEN, GUANGDONG 518106 |
| Manufacturer Country | CH |
| Manufacturer Postal | 518106 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENEVISION CENTRAL MONITORING SYSTEM |
| Generic Name | BENEVISION |
| Product Code | MSX |
| Date Received | 2019-01-04 |
| Model Number | BENEVISION CENTRAL MONITORING SYSTEM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| Manufacturer Address | 1203 NANHUAN AVENUE GUANGMING DISTRICT SHENZHEN, GUANGDONG 518106 CH 518106 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-04 |