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	09/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 81 other - the sample has been discarded.Therefore, no root cause could be determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : sample discarded.
Event or Problem Description
The customer reported to vyaire medical that they are attempting to place fetal spiral electrode for corometrics on a trial of labor after cesarean delivery (tolac) patient who was laboring naturally and the product would not stay snapped into place nor would it stick to the patient's leg.Furthermore, the customer confirmed no harm was done to the patient.
Additional Manufacturer Narrative
Result of investigation: the device history record (dhr) for lot 314665 has been reviewed, paying close attention to the foam and snap lots as well as in process inspection records such as ec12 testing.A part from ncr-ca-hl-22-007 affecting the stud lot, no abnormalities were found and products were manufactured to specification.The adhesion of the product has been reviewed as a part of capa investigation capa-000001058.All lots have been within specification.Because of this complaint and others relating to the lack of adhesiveness of this product, we have determined that the other potential root cause may be related to the adhesion of this product not being identical to the previous product.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• 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: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17927773
• Report Number: 3010838917-2023-00089
• Device Sequence Number: 20437130
• Product Code: DRX
• UDI-Device Identifier: 10190752188181
• UDI-Public: (01)10190752188181
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown