MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-30 for AVALON FM50 FETAL MONITOR M2705A manufactured by Philips Medical Systems.
[176952769]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[176952770]
The customer reported that on the (b)(6) 2019, the fetal monitor did not alarm for the loss of the fetal heart rate. The baby expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610816-2020-00037 |
| MDR Report Key | 9646410 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-12-24 |
| Date Mfgr Received | 2020-01-07 |
| Device Manufacturer Date | 2011-06-09 |
| Date Added to Maude | 2020-01-30 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. BETTY HARRIS |
| Manufacturer Street | HEWLETT-PACKARD STR.2 |
| Manufacturer City | BOEBLINGEN 71034 |
| Manufacturer Country | GM |
| Manufacturer Postal | 71034 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVALON FM50 FETAL MONITOR |
| Generic Name | PERINATAL MONITORING SYSTEM |
| Product Code | HGM |
| Date Received | 2020-01-30 |
| Model Number | M2705A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | HEWLETT-PACKARD STR.2 BOEBLINGEN 71034 GM 71034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-01-30 |