MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-09 for PHILIPS MEDICAL SYSTEMS FETAL SCALP ELECTRODE 9898 031 37631 manufactured by Philips Medical Systems.
[141735356]
Md was unable to affix the electrode to the fetal scalp. When applicator removed, noted no exposed spiral piece attached to the end. Further inspection revealed neither the applicator nor the tip had an opening for a spiral electrode to be affixed. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085747 |
| MDR Report Key | 8500849 |
| Date Received | 2019-04-09 |
| Date of Report | 2019-04-05 |
| Date of Event | 2019-03-22 |
| Date Added to Maude | 2019-04-10 |
| 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 | RISK MANAGER |
| 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 | 0 |
| Brand Name | PHILIPS MEDICAL SYSTEMS FETAL SCALP ELECTRODE |
| Generic Name | ELECTRODE, CIRCULAR (SPINE) SCALP AND APPLICATOR |
| Product Code | HGP |
| Date Received | 2019-04-09 |
| Model Number | 9898 031 37631 |
| Lot Number | 180361 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-09 |