UNK NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-04-20 for UNK NI manufactured by *.

Event Text Entries

[132789] Problem: models of cardiotocograph monitoring devices which do not include the facility of recording maternal electrocardiograph have an increased potential for confusing maternal heart rate with that of the fetus. This may lead to severe fetal problems going un-noticed. Action: action is required to confirm that the cardiotocograph is displaying the fetal heart rate and not the maternal heart rate. Users should ensure, when using cardiotocograph monitors which do not have the facility to record maternal ecg, that: a: the maternal pulse rate is regularly recorded, the maternal rate is compared with the cardiotocograph trace, the maternal pulse is compared with the signal from the loud speaker. Beware of mistaking a "doubled" maternal heart rate of fetal heart rate. B: the presence of a fetal heart beat is established by other means before using the cardiotocograph monitor. C: cardiotocograph displays are treated suspiciously if difficulty in independently establishing a fetal heart beat occurred. Users are further reminded that all monitors should be used in accordance with the mfr's instructions and that reliance on a single monitoring device is not advised. Background: mda has been informed of an incident where a baby was monitored with the ultrasonic and toco (strain gauge) transducer facility of an antepartum cardiotocograph monitor: the baby was delivered stillborn and had been dead for many hours. The cardiotograph recording showed a variable reactive trace with no signs that anything was untoward. Mda is continuing with this investigation. The monitoring of fetal wellbeing during labor, using cardiotocograph monitoring devices is commonplace. Antepartum and intrapartum models record and display fetal heart rate by ultrasonic detection of fetal heart movement. They also monitor maternal uterine activity via a toco transducer and display this as labor intensity. Intrapartum models have the add'l facility to monitor maternal ecg via chest leads and in the later stages of labor can also monitor the fetal ecg via an electrode attached to the fetal presenting part. They may also have the capability to directly monitor interuterine pressure via a fluid-couple transducer or transducer tipped catheter. Mda is aware that local policies are developed taking account of maternal views about intrusive monitoring during labor. In some cases this may mean that mfr's recommendations about the application of equipment in late stages of labor are discounted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4002190
MDR Report Key163378
Date Received1998-04-20
Date of Report1998-03-01
Date Added to Maude1998-04-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUNK
Generic NameCARDIOTOCOGRAPH (CTG) MONITORING OF FETUS DURING LABOR
Product CodeHEL
Date Received1998-04-20
Model NumberNI
Catalog NumberNI
Lot NumberNI
ID NumberNI
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key159044
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
10 1998-04-20

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