MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. MONICA NOVII WIRELESS PATCH SYSTEM; UTERINE ELECTROMYOGRAPHIC MONITOR

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/02/2024
Type of Reportable Event	Death
Additional 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.Block a: no patient information available to date.Block b2 date of death: not provided block b3 incident date: not provided.Legal manufacturer: hcs research park - 9900 innovation drive usa wauwatosa, wi 53226.
Event or Problem Description
The hospital alleged a fetal death after the clinician did prolonged trouble shooting while a fetal monitor device was in use.It was reported by the hospital that the device did not fail, and it was alleged that the event was caused by use error by the attending nurse.Ge healthcare will submit a follow-up report when the investigation has been completed.
Additional Manufacturer Narrative
Ge healthcare's (gehc) investigation has been completed.Despite multiple attempts, the end user would not provide further details related to the cause of the fetal demise, however, the end user confirmed that the novii device did not contribute to the adverse event.  the end user indicated that the clinician's actions/proficiency may have been contributing factors to the adverse event.

• Brand Name: MONICA NOVII WIRELESS PATCH SYSTEM
• Common Device Name: UTERINE ELECTROMYOGRAPHIC MONITOR
• Manufacturer (Section D): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer (Section G): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer Contact: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 20210908
• Report Number: 3008729547-2024-00015
• Device Sequence Number: 7450650
• Product Code: OSP
• UDI-Device Identifier: 00840682142700
• UDI-Public: (01)00840682142700(10)106380(11)191001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 10/20/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown