MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-16 for AVALON FM30 manufactured by Philips Medical Sys.
[1260105]
We are using 4ea philips fetal monitors -model avalon fm30's-. We have had numerous complaints regarding no calculation of the fetal heart rate, although there is a very strong audible doppler sound coming from the monitor. Without any user intervention, the fhr -fetal heart rate- will suddenly appear. We are using the monitors for nst's -non stress testing- in our high risk pregnancy pre-natal care area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012783 |
| MDR Report Key | 1481560 |
| Date Received | 2009-09-16 |
| Date of Report | 2009-09-16 |
| Date of Event | 2009-09-15 |
| Date Added to Maude | 2009-09-25 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVALON FM30 |
| Generic Name | FETAL MONITOR |
| Product Code | KXN |
| Date Received | 2009-09-16 |
| Model Number | AVALON FM30 |
| Lot Number | DE53107006 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYS |
| Manufacturer Address | ANDOVER MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-16 |