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	02/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to vyaire medical that the leg attachment pad for corometrics fetal scalp electrode cable will not stick to the skin.Furthermore, the there is no information regarding patient harm was done to the patient.
Additional Manufacturer Narrative
H3: 81 other - 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.H3 other text : device not returned yet.
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 street; buffalo NY 14204
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17822540
• Report Number: 3010838917-2023-00086
• Device Sequence Number: 16729907
• Product Code: DRX
• UDI-Device Identifier: 10190752188181
• UDI-Public: (01)10190752188181(10)314665
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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: 314665
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 10/15/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 11/09/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown