MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-08-21 for BENEVIEW MONITOR manufactured by Shenzhen Mindray Bio-medical Electronics.
[4726568]
Customer reported an issue with the beneview monitor, which may have affected pt monitoring. No pt injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[12008124]
Company rep evaluated the unit and found the co2 pump was detached from the co2 main board. Co2 pump was reattached and problem was resolved. Unit was calibrated and safety tested to factory's specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2221819-2014-00440 |
| MDR Report Key | 4037861 |
| Report Source | 05,06,07 |
| Date Received | 2014-08-21 |
| Date of Report | 2014-06-23 |
| Date of Event | 2014-06-05 |
| Date Mfgr Received | 2014-06-23 |
| Date Added to Maude | 2014-09-05 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | WISARA SETHACHUTKUL |
| Manufacturer Street | 800 MACARTHUR BLVD. |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2019958045 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENEVIEW MONITOR |
| Generic Name | PT MONITOR |
| Product Code | BZK |
| Date Received | 2014-08-21 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS |
| Manufacturer Address | CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-21 |