MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-17 for FETAL SPIRAL ELECTRODE 989803137631 manufactured by Philips Medical Systems.
[186149420]
Serial number unknown. Based on the conclusion of the investigation, it was determined that this was a serious injury associated with the fetal scalp electrode. The fetal scalp electrode was disposed of and product analysis was unable to be performed. The customer was provided with a copy of the associated field notice to be utilized to inform and retrain staff. As the infant was already delivered at the time of the incident and no further monitoring with the fetal scalp electrode was required and the customer did not require a replacement device. The device was discarded.
Patient Sequence No: 1, Text Type: N, H10
[186149421]
It was reported that the fetal scalp electrode was difficult to remove requiring medical intervention in the form of an incision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2020-01747 |
| MDR Report Key | 9842763 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERT CORNING |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FETAL SPIRAL ELECTRODE |
| Generic Name | FETAL SPIRAL ELECTRODE, SINGLE |
| Product Code | HGP |
| Date Received | 2020-03-17 |
| Model Number | 989803137631 |
| Catalog Number | 989803137631 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-17 |