MAUDE Adverse Event Report: VYAIRE MEDICAL OY VITAL SIGNS¿ LEG ATTACHMENT PAD; 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	05/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that the 2464aao-20 leg attachment pad for corometrics fetal scalp electrode cable was faulty and the fetal heart rate does not trace appropriately which can put the patient/newborn at risk.At this time, the customer has not provided any information regarding patient harm or injury associated with the reported event.
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Device not returned yet.
Additional Manufacturer Narrative
Result of investigation: vyaire medical was able to confirm the issue.Per inspection interval is verifying leg pad dimensional compatibility with the connector wire.All checks showed electrodes were conforming with the connector wire and generated for mis-formed snaps.The vendor provided a tooling modification that met the print better.During our review, it determined that this was the first snap lot of the new tooling modification.

• Brand Name: VITAL SIGNS¿ LEG ATTACHMENT PAD
• 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 st; buffalo NY 14204
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17302790
• Report Number: 3010838917-2023-00068
• Device Sequence Number: 17801859
• Product Code: DRX
• UDI-Device Identifier: 10190752188181
• UDI-Public: (01)10190752188181(10)341329
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE
• Device Catalogue Number: 2464AAO-20
• Device Lot Number: 341329
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 35 YR
• Patient Sex: Female
• Patient Race: White