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 2011-05-10 for OB TRACEVUE SERVER M1383D manufactured by Philips Medical Systems.
[2052233]
The customer reported that alarms were not alarming and that they are unable to enable the alerts.
Patient Sequence No: 1, Text Type: D, B5
[9010508]
(b)(4): the customer reported that alarms were not alarming and that they were unable to enable the alerts. The customer stated that their devices are configured correctly and requested that a philips field service engineer (fse) go on site to resolve the issue. Based on the current information, the customer resolved the issue on their own after they determined that the alarm function on the server was muted. While the device display provides visual indicators of alarms/alerts occurring, the user may not recognize the failure or the patient need for additional therapy. Control of alarming functions is adequately described in the device labeling (instructions for use). Consideration of this complaint and similar complaints supports that there is no design, manufacturing, materials, or labeling problem. No further action or investigation is warranted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610816-2011-00233 |
| MDR Report Key | 2126040 |
| Report Source | 05,06,07 |
| Date Received | 2011-05-10 |
| Date of Report | 2011-04-27 |
| Date Mfgr Received | 2011-04-27 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2011-07-11 |
| 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 | NANCY ATAIDE |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786597429 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OB TRACEVUE SERVER |
| Product Code | HFM |
| Date Received | 2011-05-10 |
| Model Number | M1383D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN RD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-10 |