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 2019-03-21 for FETAL SPIRAL ELECTRODE 989803137631 manufactured by Philips Medical Systems.
[139461852]
Phone not provided. Serial number not provided. A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[139461853]
The customer reports scalp lesions of newborns, from the application of fetal monitoring (scalp) during labor. The patient required administration of an antibiotic therapy for 10 days.
Patient Sequence No: 1, Text Type: D, B5
[142209960]
It was reported that a newborn patient was born via? Normal birth? And the doctor used the device before the delivery time for monitoring of the fetal heart. The patient had inflammation at the site of the insertion of the fse. A return material authorization was issued for return of the device involved in the incident for evaluation. However, philips was advised that the hospital team did not retain the product. Therefore, no product will be returned for evaluation. Philips was also informed that there was no report of the tip breaking and the hospital does not have information about the device, batch or any other details, including why the antibiotic therapy was needed. Per a philips senior clinical informatics specialist: "my clinical conclusion based on the limited incident information is the intended use of the fse device requires insertion into the scalp tissue of the fetus. This action inherently results in skin integrity interruption to allow the attachment of the spiral electrode. " the customer was provided with a letter explaining the investigation that had occurred. Philips is considering this a malfunction of cause unknown for reporting purposes only.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2019-02169 |
| MDR Report Key | 8440416 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-21 |
| Date of Report | 2019-03-13 |
| Date of Event | 2018-10-07 |
| Date Mfgr Received | 2019-03-13 |
| Date Added to Maude | 2019-03-21 |
| 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 | 2019-03-21 |
| Model Number | 989803137631 |
| Catalog Number | 989803137631 |
| 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 | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-21 |