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 2011-06-08 for PHILIPS OBTV SERVER M1383D manufactured by Philips Medical Systems.
[2119909]
The customer reported that they were experiencing an issue with receiving alarm alerts. No patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5
[9190083]
(b)(4). The customer reported that they were experiencing an issue with receiving alarm alerts and the sound control option was not available (greyed out). No patient harm was reported. 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. Sometimes the issue may be determined to not be a malfunction but related to a configuration of the obtv (alarming permission based on the hospital protocol, and or lowered audible sound at the fetal monitor). Philips is in the process of obtaining additional information regarding this incident and the complaint is still under investigation. A final report will be submitted once the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610816-2011-00317 |
| MDR Report Key | 2145030 |
| Report Source | 05,06,07 |
| Date Received | 2011-06-08 |
| Date of Report | 2011-05-17 |
| Date Mfgr Received | 2011-05-17 |
| Date Added to Maude | 2011-07-25 |
| 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 RD. |
| 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 | PHILIPS OBTV SERVER |
| Product Code | HFM |
| Date Received | 2011-06-08 |
| Model Number | M1383D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-06-08 |