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

Model Number	VITAL SIGNS¿ FETAL SPIRAL ELECTRODE FOR COROMETRICS
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, vyaire is pursuing additional information and sample availability for evaluation.Any additional information provided by the customer will be included in a follow-up report.Due diligence is ongoing.
Event or Problem Description
The customer reported that the fetal spiral electrode for corometrics did not pick up fetal heart rate when applied by physician during labor and delivery.There was no indication of patient harm or medical intervention during initial contact.
Additional Manufacturer Narrative
Device evaluation: g4, g7, h2, h3, h6 and h10.Dhr lot number: s06191-f was reviewed and not issues were found.After verifying the dhr, pfmea, retained sample, personal training and taking a walk around of the line, it is concluded that everything is under specification and operations are carried out according to work instructions.As the sample was not available to perform other additional tasks, no root cause was determined, it was not possible to identify or replicate the failure.

• Brand Name: VITAL SIGNS FETAL SPIRAL ELECTRODE FOR COROMETRICS
• Common Device Name: ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9919480
• Report Number: 3003678543-2020-00001
• Device Sequence Number: 2900638
• Product Code: HGP
• UDI-Device Identifier: 10885403248962
• UDI-Public: (01)10885403248962(10)S06191-F
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K792669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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: VITAL SIGNS¿ FETAL SPIRAL ELECTRODE FOR COROMETRICS
• Device Catalogue Number: 7000AAO
• Device Lot Number: S06191-F
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 23 YR