MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-01-29 for DPM CENTRAL STATION manufactured by Mindray Ds Usa, Inc..
[3172276]
The customer reported a loss of communication between the ambulatory telepack and dpm central station. No pt injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[10508756]
The company rep evaluated the system and verified the reported problem. The customer was provided with a replacement ambulatory telepack. The system was tested to factory's specifications. It functioned normally and was returned to use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2221819-2013-00020 |
| MDR Report Key | 2981007 |
| Report Source | 06,07 |
| Date Received | 2013-01-29 |
| Date of Report | 2013-01-30 |
| Date of Event | 2012-09-11 |
| Date Added to Maude | 2013-04-16 |
| 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 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DPM CENTRAL STATION |
| Generic Name | NONE |
| Product Code | EIH |
| Date Received | 2013-01-29 |
| 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 | 2013-01-29 |