MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FETAL SPIRAL ELECTRODE FETAL SPIRAL ELECTRODE, SINGLE

Model Number 989803137631

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Abrasion (1689)

Event Date 09/05/2018

Event Type  Injury  

Manufacturer Narrative

Phone not provided. Serial number not provided. A follow-up report will be submitted once the investigation is complete.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: FETAL SPIRAL ELECTRODE
• Type of Device: FETAL SPIRAL ELECTRODE, SINGLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8440432
• MDR Text Key: 139462074
• Report Number: 1218950-2019-02164
• Device Sequence Number: 1
• Product Code: HGP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K030691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 989803137631
• Device Catalogue Number: 989803137631
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/21/2019 Patient Sequence Number: 1