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 2018-06-07 for BENEVISION CENTRAL MONITORING SYSTEM 115-034413-00 manufactured by Shenzhen Mindray Bio-medical Electronics Co., Ltd.
[110332367]
The company service representative evaluated the system and confirmed the unit was generating visual and audible alarms. The company service representative increased the volume and locked the display with the authority of customer biomed present and a new password was reset. The customer is not alleging any device malfunction and reported that no additional information will be available. 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
[110332368]
The customer reported that the audio level in the display menu of the central monitoring station had been turned down and a patient being monitored on the system expired. Note: the customer does not allege that the system missed an alarm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009156722-2018-00006 |
| MDR Report Key | 7577371 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-07 |
| Date of Report | 2018-05-14 |
| Date of Event | 2018-05-12 |
| Date Facility Aware | 2018-05-14 |
| Report Date | 2018-06-04 |
| Date Reported to Mfgr | 2018-06-04 |
| Date Mfgr Received | 2018-05-14 |
| Date Added to Maude | 2018-06-07 |
| 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 HI-TECH INDUSTRIAL PARK |
| Manufacturer City | SHENZHEN, NANSHAN 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 | BENEVISION |
| Product Code | MSX |
| Date Received | 2018-06-07 |
| 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 | 1203 NANHUAN AVENUE GUANGMING GUANGMING DISTRICT SHENZHEN, GUANGDONG 518106 CH 518106 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-06-07 |