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 2018-03-23 for BENEVISION CENTRAL MONITORING SYSTEM 115-034413-00 manufactured by Shenzhen Mindray Bio-medical Electronics Co., Ltd.
[103363526]
The company service representative evaluated the system and confirmed the unit was generating visual and audible alarms. The audible alarm volume was noted as set to 10 (low). The company service representative increased the volume from 10 to 50 and locked the display with the authority of customer biomed present. System logs were collected for further evaluation. The logs revealed that multiple alarms were generated during the time of the reported event. The reported event is likely attributed to the low volume (10), set by the user. The operative manual provides a warning to remind the user of the risk of setting alarm volume to a low level. There was no device malfunction. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103363527]
The customer reported they did not "hear" an alarm at the benevision central station. (note: the report does not allege a missed alarm. ) customer report that the patient being monitored by the central station expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009156722-2018-00002 |
| MDR Report Key | 7366783 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-23 |
| Date of Report | 2018-02-22 |
| Date of Event | 2018-02-21 |
| Date Facility Aware | 2018-02-22 |
| Report Date | 2018-03-22 |
| Date Reported to Mfgr | 2018-03-22 |
| Date Mfgr Received | 2018-02-22 |
| Date Added to Maude | 2018-03-23 |
| 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 | 2# BUILDING, PLANT A SHIGUANG SHANGCUN COMMUNITY, GONGMING, |
| Manufacturer City | SHENZHEN, 518056 |
| Manufacturer Country | CH |
| Manufacturer Postal | 518056 |
| 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 | 2018-03-23 |
| Model Number | BENEVISION CENTRAL MONITORING SYSTEM |
| Catalog Number | 115-034413-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| Manufacturer Address | 2# BUILDING, PLANT A SHIGUANG SHANGCUN COMMUNITY, GONGMING, SHENZHEN, 518056 CH 518056 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-03-23 |