MAUDE Adverse Event Report: VYAIRE MEDICAL OY VITAL SIGNS; ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR

Model Number	7000AAO
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Attempted to use fetal spiral electrode and it did not work accurately.It did not pick up fetal heart rate when applied by physician.

• Brand Name: VITAL SIGNS
• Common Device Name: ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR
• Manufacturer (Section D): VYAIRE MEDICAL OY; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 9753466
• Report Number: 9753466
• Device Sequence Number: 16810275
• Product Code: HGP
• UDI-Device Identifier: 10885403248962
• UDI-Public: (01)10885403248962
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/10/2020
• Report Date (Section F): 01/10/2020

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: 7000AAO
• Device Catalogue Number: 7000AAO
• Device Lot Number: S06191-F
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/10/2020