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 2017-06-07 for BENEVISION CENTRAL MONITORING SYSTEM manufactured by Shenzhen Mindray Bio-medical Electronics, Ltd..
[76980700]
The investigation of the reported event is in process, results pending the analysis of data. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76980701]
It was reported that an alarm was missed for a ventricular tachycardia event while a patient was being monitored on the benevision central station. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007222337-2017-00014 |
| MDR Report Key | 6620901 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-07 |
| Date of Report | 2017-04-27 |
| Date of Event | 2017-04-26 |
| Date Facility Aware | 2017-04-27 |
| Report Date | 2017-06-23 |
| Date Reported to Mfgr | 2017-06-23 |
| Date Mfgr Received | 2017-06-23 |
| Date Added to Maude | 2017-06-07 |
| 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 | KEJI 12TH ROAD SOUTH |
| Manufacturer City | NANSHAN, SHENZHEN 518057 |
| Manufacturer Country | CH |
| Manufacturer Postal | 518057 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENEVISION CENTRAL MONITORING SYSTEM |
| Generic Name | CENTRAL MONITORING STATION |
| Product Code | MSX |
| Date Received | 2017-06-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS, LTD. |
| Manufacturer Address | KEJI 12TH ROAD SOUTH NANSHAN, SHENZHEN 518057 CH 518057 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-07 |