MAUDE Adverse Event Report: MONICA HEALTHCARE LIMITED NOVII; UTERINE ELECTROMYOGRAPHIC MONITOR

Model Number ID YOM6961-MON

Device Problem Patient Data Problem (3197)

Patient Problem Insufficient Information (4580)

Event Date 11/12/2020

Event Type  malfunction  

Event Description

Novii monitor transposed fetal heart rate and maternal heart rate- visualized on the tracing.

• Brand Name: NOVII
• Type of Device: UTERINE ELECTROMYOGRAPHIC MONITOR
• Manufacturer (Section D): MONICA HEALTHCARE LIMITED; 3000 n. grandview blvd.; waukesha WI 53188
• MDR Report Key: 10945632
• MDR Text Key: 219522446
• Report Number: 10945632
• Device Sequence Number: 1
• Product Code: OSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ID YOM6961-MON
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8030 DA
• Patient Weight: 97