MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-05-10 for BENEVISION CENTRAL MONITORING SYSTEM 300DE-PA00004 manufactured by Shenzhen Mindray Bio-medical Electronics Co., Ltd.
[74891015]
The company representative evaluated they system and observed that after rebooting the central station that the unit generated an error that required the replacement of the hard drive, therefore the technician was unable to obtain additional logs directly from the system. The hard drive was replaced and the system was tested to factory specification. The tel-200 involved in the report was tested and function per specifications. Full disclosure logs from the time of the reported event were provided by the customer and the two reported issues were investigated: 1) missed low heart rate and asystole alarm. 2) unit not storing full disclosure reports on day post the report. Upon review of the full disclosure logs it was noted that the system called asystole and numerous low heart rate alarms at the time of the report. In addition, it was recorded in the logs that the user acknowledged these alarms including the asystole alarm. Additionally, it was noted that user discharged the patient and elected not to store the patient data on discharge, therefore no full disclosure were stored after patient discharge. In conclusion, the central station functioned per specifications at the time of the reported event, there was no device malfunction. The hard drive failure reported during the systems evaluation is unrelated to the original report. No information related to the patient or to the patient final outcome is available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[74891016]
The customer reported that a patient admitted on a tele-200 transmitter experienced a drop in heart rate and went into asystole at 10:46am and 10:52am but no audible low heart rate alarm and no asystole alarm was emitted by the central station. The customer reported they were able to obtain the full disclosure logs from the time of the event but on the following day, they were unable to retrieve any additional full disclosure data.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009156722-2017-00012 |
| MDR Report Key | 6559380 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-05-10 |
| Date of Report | 2017-04-10 |
| Date of Event | 2017-04-10 |
| Date Facility Aware | 2017-04-10 |
| Report Date | 2017-04-10 |
| Date Reported to Mfgr | 2017-04-10 |
| Date Mfgr Received | 2017-04-10 |
| Date Added to Maude | 2017-05-10 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2017-05-10 |
| Model Number | BENEVISION CENTRAL MONITORING SYSTEM |
| Catalog Number | 300DE-PA00004 |
| 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 | 2017-05-10 |