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

Model Number 107-PT-020

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Diminished Pulse Pressure (2606)

Event Date 06/24/2020

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.No patient information provided.Serial number: not provided.Report source: (b)(6).Date of device manufacture: unknown as no serial number provided.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that on (b)(6) 2020 at 7:10 am, the staff reported loss of signal for 40 minutes, and no fetal heart rate.Attending healthcare providers reportedly were changing leads and doing other things because they didn't realize that it wasn't a connectivity issue, it was an issue with the baby.At 8:00 am, a caesarian section was performed.The baby died.There was no allegation of device malfunction.Ge healthcare's investigation into the reported occurrence is ongoing.

Manufacturer Narrative

The root cause is use error related to delay in execution of the clinical procedures as necessitated at the time of the incident as per the standard of care.The device was found to be functioning as intended.

• 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
• Manufacturer (Section G): MONICA HEALTHCARE LTD; unit 8, interchange 25; business park bostocks lane; nottingham NG10 5QG; UK NG10 5QG
• Manufacturer Contact: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 14218843
• MDR Text Key: 290163313
• Report Number: 3006340424-2022-00001
• Device Sequence Number: 1
• Product Code: OSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death