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 PANORAMA CENTRAL STATION WITH TELEMETRY manufactured by Mindray Ds Usa, Inc..
[4726564]
Customer reported an issue with the panorama central station, which may have affected telemetry monitoring. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[12277298]
Company representative evaluated the system and found the antennas had no power. Corrections including clearing the system's error logs and rebooting the power to the system server. System was safety tested to factory's specifications. Issue may be the result of a problem with the site's back up generator.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2221819-2014-00457 |
| MDR Report Key | 4037876 |
| Report Source | 05,06,07 |
| Date Received | 2014-08-21 |
| Date of Report | 2014-06-30 |
| Date of Event | 2014-06-28 |
| Date Mfgr Received | 2014-06-30 |
| Date Added to Maude | 2014-09-04 |
| 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 |
| 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 | PANORAMA CENTRAL STATION WITH TELEMETRY |
| Generic Name | CENTRAL MONITORING STATION |
| Product Code | BZK |
| Date Received | 2014-08-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MINDRAY DS USA, INC. |
| Manufacturer Address | MAHWAH NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-21 |