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

Model Number 107-PT-020

Device Problems Defective Alarm (1014); Device Sensing Problem (2917)

Patient Problem Death (1802)

Event Date 06/19/2019

Event Type  Death  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Unique device identifier: (b)(4).Device evaluated by mfr: device evaluation anticipated, but not yet begun.

Event Description

The hospital reported a loss of fetal heart rate (fhr) signal with no alarms allegedly resulting in fetal distress and serious injury ending in patient death.

Manufacturer Narrative

Ge healthcare product engineering performed an investigation of this event.On july 2, 2019, ge healthcare personnel visited the site of the event.The novii interface, novii pod, novii cables, and novii power supply were tested and found to be functioning according to manufacturer specifications.Testing did identify issues with two of the three novii pods, but these issues were proven to be incapable of contributing to the event (fetal heart rate (fhr) gap during monitoring).Analysis of the cardiotocogram tracing (ctg) strip did not reveal any malfunction of the novii system.Analysis of the event and alert logs showed that the system functioned as intended with respect to alarms.The logs showed that visual alarms were triggered within 5 minutes of the fhr gap per the device specifications.The established root cause is user error since non-reassuring tracing should have initiated intervention in a timely manner.

• Brand Name: NOVII
• Type of Device: UTERINE ELECTROMYOGRAPHIC MONITOR
• Manufacturer (Section D): MONICA HEALTHCARE LTD; unit 8, interchange 25; business park bostocks lane; nottingham NG10 5QG; UK NG10 5QG
• MDR Report Key: 8755274
• MDR Text Key: 149859800
• Report Number: 3006340424-2019-00001
• Device Sequence Number: 1
• Product Code: OSP
• Combination Product (y/n): N
• PMA/PMN Number: K140862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 107-PT-020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death