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 2018-06-18 for BENEVISION CENTRAL MONITORING SYSTEM 115-034413-00 manufactured by Shenzhen Mindray Bio-medical Electronics Co., Ltd.
[111659567]
Ecg strips corresponding to the report at 11:19:38 were reviewed but a determination of the possible beat classification could not be made and no conclusions could obtained. Ecg strips 20 seconds pre and post the time are needed to assess beat classification and if the user established criteria for ventricular tachycardia were met, but these could not be provided by the facility. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[111659568]
It was reported that on (b)(6) 2018 the (b)(6) station may have failed to produce an alarm; at 11:19:38 it was reported that a ventricular tachycardia alarm was expected but no alarm was generated by the system. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009156722-2018-00007 |
| MDR Report Key | 7609478 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-18 |
| Date of Report | 2018-05-23 |
| Date of Event | 2018-05-23 |
| Date Facility Aware | 2018-05-23 |
| Report Date | 2018-06-18 |
| Date Reported to Mfgr | 2018-06-18 |
| Date Mfgr Received | 2018-05-23 |
| Date Added to Maude | 2018-06-18 |
| 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 | 2018-06-18 |
| Model Number | BENEVISION CENTRAL MONITORING SYSTEM |
| Catalog Number | 115-034413-00 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-06-18 |