MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-14 for INTELLIVUE MP50 M8004A manufactured by Philips Medical Systems.
[91931763]
Patient Sequence No: 1, Text Type: N, H10
[91931764]
Bio med log: electronic health record (ehr) not downloading to monitor. Monitor tested, confirmed data not transferring from monitor to ehr. Philips tech support called, parts ordered and installed. Six weeks later - above issue still exists. More trouble shooting with philips support and ehr it but no solution. Three months passed and issue continues. New network card obtained and installed, replacing card purchased 6 months prior. Issue did not resolve. Finally after 4 months, decision made to replace the monitor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7027829 |
| MDR Report Key | 7027829 |
| Date Received | 2017-11-14 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-07-28 |
| Report Date | 2017-09-29 |
| Date Reported to FDA | 2017-09-29 |
| Date Reported to Mfgr | 2017-09-29 |
| Date Added to Maude | 2017-11-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Brand Name | INTELLIVUE MP50 |
| Generic Name | BEDSIDE PHYSIOLOGIC MODULAR MONITOR |
| Product Code | BZQ |
| Date Received | 2017-11-14 |
| Model Number | M8004A |
| Catalog Number | M8004A |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-14 |