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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES - CRITIKON DE MEXICO S. DE R.L. DE C.V. GE NOVII FMS / MONICA NOVII WIRELESS PATCH SYS.; UTERINE ELECTROMYOGRAPHIC MONITOR
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GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES - CRITIKON DE MEXICO S. DE R.L. DE C.V. GE NOVII FMS / MONICA NOVII WIRELESS PATCH SYS.; UTERINE ELECTROMYOGRAPHIC MONITOR Back to Search Results
Device Problem Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2020
Event Type  Injury  
Event Description
Our ob expert identified a potential issue with the monica novii wireless patch system.If there is an acute event in utero, such as placental abruption or uterine rupture, it can disrupt the fecg signal and cause the monica novii wireless patch system to stop recording the fetal heart rate, while continuing to graph the contractions and maternal heart rate.Unless there are clinical signs of something being wrong in utero (i.E.Blood, cramping etc.), valuable time may be spent trying to reacquire the fetal heart rate in the face of an acute event, possibly resulting in fetal demise or injury to the fetal brain.Fda safety report id # (b)(4).
 
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Brand Name
GE NOVII FMS / MONICA NOVII WIRELESS PATCH SYS.
Type of Device
UTERINE ELECTROMYOGRAPHIC MONITOR
Manufacturer (Section D)
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES - CRITIKON DE MEXICO S. DE R.L. DE C.V.
MDR Report Key14257503
MDR Text Key290558179
Report NumberMW5109465
Device Sequence Number1
Product Code OSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/29/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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