MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-06-20 for BENEVISION CENTRAL MONITORING SYSTEM manufactured by Shenzhen Mindray Bio-medical Electronics Co., Ltd.
[112315753]
(b)(6) service representative visited the site and collected error lost from multiple systems. An evaluation is underway, however, it noted that the site is unable to provide specific information about the system involved or other evidence of the event such as ecg strips. Source of the report: mw5077371. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[112315754]
Customer reported that patient began having pauses of less than 2 seconds. First pause at 16. 50- alarm did not sound, rhythm strip did print with occurrence. Second pause at 17. 27- alarm did not sound and rhythm strip did not print with occurrence. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009156722-2018-00008 |
| MDR Report Key | 7622659 |
| Report Source | USER FACILITY |
| Date Received | 2018-06-20 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-05-11 |
| Date Facility Aware | 2018-05-29 |
| Report Date | 2018-05-21 |
| Date Reported to FDA | 2018-05-21 |
| Date Reported to Mfgr | 2018-06-20 |
| Date Mfgr Received | 2018-05-29 |
| Date Added to Maude | 2018-06-20 |
| 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 | 2018-06-20 |
| Model Number | BENEVISION CENTRAL MONITORING SYSTEM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-06-20 |