MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-15 for AVALON FM50 manufactured by Phillips.
[4842445]
On (b)(6) 2014, at 13:35, a 40 weeks and 5 days pregnant female presented to hospital for induction of labor secondary to post term pregnancy and newly diagnosed gestational hypertension. Fetal monitor was connected. On (b)(6) 2014, at 21:27, a female infant was born with tight double nuchal cord noted and handed immediately to pediatrician. Chest compressions and respiratory assistance were started and code pink called at less than one minute of life with apgars 0/0/0/2. The infant was resuscitated and transported via critical care team to outside facility nicu. The infant expired on (b)(6) 2014, at 06:03.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037732 |
| MDR Report Key | 4021145 |
| Date Received | 2014-08-15 |
| Date of Report | 2014-08-04 |
| Date of Event | 2014-05-03 |
| Date Added to Maude | 2014-08-19 |
| 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 |
| 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 FM50 |
| Generic Name | FETAL MONITOR |
| Product Code | KNG |
| Date Received | 2014-08-15 |
| Model Number | FM50 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILLIPS |
| Manufacturer Address | ANDOVER 01810109 01810 1099 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-08-15 |