MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. VITAL SIGNS; ELECTRODE, ELECTROCARDIOGRAPH

Model Number 2464AAO-20

Device Problems Unable to Obtain Readings (1516); Defective Device (2588)

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

Event Date 05/28/2023

Event Type  malfunction  

Event Description

This event has occurred numerous times.Most recent report: the leg attachment pad that connects to the fetal scalp electrode is new and they are faulty.It has not been working and is being replaced many times.The fetal heart rate does not trace appropriately which can put the patient/newborn at risk.Need to change back to the old ones or find a replacement.

• Brand Name: VITAL SIGNS
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 26125 north riverwoods blvd; mettawa IL 60045
• MDR Report Key: 17117626
• MDR Text Key: 317054989
• Report Number: 17117626
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2464AAO-20
• Device Catalogue Number: 2464AAO-20
• Device Lot Number: 341329
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2023
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12775 DA
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White