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	07/24/2023
Type of Reportable Event	Malfunction
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.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that the 2464aao-20 leg attachment pad for corometrics fetal scalp electrode cable was not very sticky and comes off during an assessment with the patient.Further investigations with the users, it has revealed it is not only an adhesive issue, but also connection between the pad and the spiral electrode.The customer confirmed that there was no patient harm associated with the reported event.

• Brand Name: VITAL SIGNS¿¢ LEG ATTACHMENT PAD
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2 helsinki ete; la-suomen laani, finland fin; helsinki ; FI
• Manufacturer (Section G): GRAPHIC CONTROLS ACQUISITION CORP.; 400 exchange st; buffalo
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17638669
• Report Number: 3010838917-2023-00078
• Device Sequence Number: 7816252
• Product Code: DRX
• UDI-Device Identifier: 10190752188181
• UDI-Public: (01)10190752188181(10)337569
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2023

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: 337569
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/28/2023
• 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 Sex: Unknown