MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for VITAL SIGNS 7000AAO manufactured by Vyaire Medical Oy.
[180867965]
Attempted to use fetal spiral electrode and it did not work accurately. It did not pick up fetal heart rate when applied by physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9753466 |
| MDR Report Key | 9753466 |
| Date Received | 2020-02-26 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-07-02 |
| Report Date | 2020-01-10 |
| Date Reported to FDA | 2020-01-10 |
| Date Reported to Mfgr | 2020-02-26 |
| Date Added to Maude | 2020-02-26 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL SIGNS |
| Generic Name | ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR |
| Product Code | HGP |
| Date Received | 2020-02-26 |
| Model Number | 7000AAO |
| Catalog Number | 7000AAO |
| Lot Number | S06191-F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL OY |
| Manufacturer Address | 26125 N. RIVERWOODS BLVD. METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |