MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-19 for BENEVISION CENTRAL MONITORING SYSTEM manufactured by Shenzhen Mindray Bio-medical Electronics, Ltd..
[73216706]
An on site investigation was performed by mindray service engineer and no anomaly was found on the tm80 telemetry monitoring system and the benevision cms. The log files and the patient waveform were returned for analysis and it was found that at the 22:51:49, (b)(6) 2017, there was a "ecg lead off" alarm initiated and the ecg lead was reconnected about an hour and a half later (0:18:22, (b)(6) 2017). After the ecg leads were reconnected, the cms received "asystole" alarms. At 00:24:32, (b)(6) 2017, there was an operation "press the alarm mute" in the log, which indicated the alarm sound had been turned off at that time. According to above mentioned analysis ,we concluded that the tm80 and the cms were working properly. No malfunction was found.
Patient Sequence No: 1, Text Type: N, H10
[73216707]
The customer reported that during (b)(6) at 10:00 pm to (b)(6) at 2:00 am, a patient died while being monitored with the tm80 telemetry monitoring system. The benevision central monitoring system did not alarm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007222337-2017-00011 |
| MDR Report Key | 6505392 |
| Date Received | 2017-04-19 |
| Date of Report | 2017-03-24 |
| Date of Event | 2017-03-20 |
| Date Mfgr Received | 2017-03-24 |
| Date Added to Maude | 2017-04-19 |
| 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 |
| 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 HIGH-TECH INDUSTRIAL PARK |
| Manufacturer City | NANSHAN, SHENZHEN 518057 |
| Manufacturer Country | CH |
| Manufacturer Postal | 518057 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BENEVISION CENTRAL MONITORING SYSTEM |
| Generic Name | CENTRAL MONITORING SYSTEM |
| Product Code | MSX |
| Date Received | 2017-04-19 |
| Device Availability | * |
| 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 HIGH TECH INDUSTRIAL PARK NANSHAN, SHENZHEN 518057 CH 518057 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-04-19 |