MAUDE Adverse Event Report: VYAIRE MEDICAL OY LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to vyaire medical that the pads, fetal scalp electrode attachment keeps coming off, making it impossible to monitor the baby's heart rate.Recurrent late and protracted decelerations were occurring in the patient.Two different fse grounding pads were used but the device continued to fall off of the pad.Additionally, there was no information on patient harm.
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2; etela-suomen laani,; helsinki, 00510 ; FI 00510
• Manufacturer (Section G): GRAPHIC CONTROLS ACQUISITION CORP.; 400 exchange street; buffalo NY 14204
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, CA 92618
• MDR Report Key: 15765019
• Report Number: 3010838917-2022-00025
• Device Sequence Number: 18198063
• Product Code: DRX
• UDI-Device Identifier: 10190752145337
• UDI-Public: (01)10190752145337
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 10/17/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE
• Device Catalogue Number: 2464AAO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 11/09/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown