FDA Adverse Event Injury Summary report: N

COROMETRICS QWICKCONNECT PLUS SPIRAL ELECTRODE

MDR report key: 1851239 · Received September 23, 2010

Report

Report Number: 9613557-2010-00008
Event Type: Injury
Date Received: September 23, 2010
Date of Event: August 12, 2010
Report Date: September 23, 2010
Manufacturer: GE HEALTHCARE
Product Code: HGP
PMA / PMN Number: K792669
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER REPORTEDLY DISCARDED THE FETAL SCALP ELECTRODE, THEREFORE, THE DEVICE IS UNAVAILABLE FOR INVESTIGATION. SUBSEQUENT ATTEMPTS TO COLLECT INFO AND F/U WITH THE CUSTOMER WERE UNSUCCESSFUL. GE HEALTHCARE PROVIDED THE CUSTOMER WITH A REFERENCE GUIDE ENTITLED "APPLICATION OF THE COROMETRICS QWICK CONNECT PLUS SPIRAL ELECTRODE." THE REFERENCE GUIDE IS INCLUDED WITH THIS REPORT.

Description of Event or Problem · 1

A CUSTOMER REPORTED THAT AN INFANT INCURRED A LACERATION DURING REMOVAL OF THE FETAL SCALP ELECTRODE. A NURSE REPORTEDLY HAD PLACED THE FETAL SCALP ELECTRODE, DUE TO POOR FETAL HEART RATE. THE INFANT'S FETAL HEART RATE DECREASED WITH MATERNAL PUSHING; THEREFORE, AN IMMEDIATE CAESAREAN SECTION WAS REQUIRED. A NURSE ATTEMPTED TO REMOVE THE FETAL SCALP ELECTRODE, BUT REPORTEDLY EXPERIENCED DIFFICULTY. THE NURSE THEN CUT THE FETAL SCALP ELECTRODE, ATTEMPTED TO REMOVE IT AGAIN, AND PULLED THE ELECTRODE OUT. A LACERATION WAS NOTED FOLLOWING DELIVERY, AND SEVERAL SUTURES WERE PLACED DUE TO BLEEDING. THE STAFF REPORTEDLY BELIEVES THAT THE INJURY WAS DUE TO THE FETAL SCALP ELECTRODE BEING PULLED OFF OF THE INFANT'S HEAD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COROMETRICS QWICKCONNECT PLUS SPIRAL ELECTRODE	FETAL SCALP SPIRAL ELECTRODE	HGP	GE HEALTHCARE		S30091

Patients

Seq	Age	Sex	Outcome	Treatment
1	1 DA		Other\| R