MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-06 for MERGE CLIENT DOCUMENTATION SYSTEM manufactured by Pitney Bowes Software.
[104896215]
During emergent case the merge documentation system was not working, call made to it, merge and physician notified. Case was performed by documenting on paper then entering in other merge system at a later time. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076362 |
| MDR Report Key | 7406219 |
| Date Received | 2018-04-06 |
| Date of Report | 2018-04-05 |
| Date of Event | 2018-02-06 |
| Date Added to Maude | 2018-04-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MERGE CLIENT DOCUMENTATION SYSTEM |
| Generic Name | SOFTWARE, TRANSMISSION AND STORAGE |
| Product Code | NSX |
| Date Received | 2018-04-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PITNEY BOWES SOFTWARE |
| Manufacturer Address | 350 JORDAN RD. TROY NY 12180 US 12180 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-06 |