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.
[139462074]
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
[139462075]
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
[143520077]
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. A month after discharge from hospital, was readmitted to the neonatal exam room for a head echography, as the newborn presented an under-cutaneous neoformation similar to an atheroma. The impression was confirmed by the results of the echography and visual-tactile examination as the cyst was mobile compared to lower layers and not painful at touch. After another month, the mother brought back the newborn to the er because some? Substance/material? Was oozing from the cyst. In the er the surgeon removed, with surgical tweezers, some spiral shaped metallic fragments compatible with the scalp electrode. A return material authorization was issued for the return of the device involved in the incident for evaluation. Philips was advised that the hospital team was not aware of the occurrence of the broken electrode. Therefore, the device was not retained. Additional information was requested, but the distributor was unable to confirm how this had occurred. Therefore, we are considering this a malfunction of cause unknown for reporting purposes only.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2019-02164 |
| MDR Report Key | 8440432 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-21 |
| Date of Report | 2019-03-13 |
| Date of Event | 2018-09-05 |
| 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 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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. Other | 2019-03-21 |