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

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.On follow-up, the customer confirmed that the sample was thrown away after patient use.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : product discarded.

Event Description

The customer reported that the leg attachment pad would not stay connected to the cable.The nurse will push down and pinch it, and it will transmit properly, but when they let go, it creates an artifact, and the fetal heart rate cannot be traced.The customer confirmed that there was no patient harm associated with the reported event.

• Brand Name: VITAL SIGNS¿ LEG ATTACHMENT PAD
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2 helsinki ete; la-suomen laani; helsinki ; FI
• Manufacturer (Section G): GRAPHIC CONTROLS ACQUISITION CORP.; 400 exchange st; buffalo NY
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18509773
• MDR Text Key: 332871525
• Report Number: 3010838917-2024-00095
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 10190752188181
• UDI-Public: (01)10190752188181
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 90 KG