MAUDE Adverse Event Report: VYAIRE MEDICAL OY VITAL SIGNS¿ FETAL SPIRAL ELECTRODE FOR COROMETRICS; ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR

Model Number	ELECTRODES, FETAL SCALP (FSE), 50/CASE
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the leg attachment pad would not stay connected to the cable.The nurse will push down and pinch it, and it will transmit properly, but when they let go, it creates an artifact, and the fetal heart rate cannot be traced.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.On follow-up, the customer confirmed that the sample was thrown away after patient use.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : product discarded.

• Brand Name: VITAL SIGNS¿ FETAL SPIRAL ELECTRODE FOR COROMETRICS
• Common Device Name: ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2 helsinki ete; la-suomen laani; helsinki ; FI
• Manufacturer (Section G): PRECISION CONCEPTS COSTA RICA SA; saret free zone building d3; p.o. box 74-4002; alajuela ; CS
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18509777
• Report Number: 3010838917-2024-00096
• Device Sequence Number: 15419775
• Product Code: HGP
• UDI-Device Identifier: 10190752142176
• UDI-Public: (01)10190752142176
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K792669
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2024

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
• Operator of Device: Health Professional
• Device Model Number: ELECTRODES, FETAL SCALP (FSE), 50/CASE
• Device Catalogue Number: 7000AAO
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 01/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 90 KG