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

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

Event Type  malfunction  

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 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.

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
• Type of Device: ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9919480
• MDR Text Key: 187412472
• Report Number: 3003678543-2020-00001
• Device Sequence Number: 1
• Product Code: HGP
• UDI-Device Identifier: 10885403248962
• UDI-Public: (01)10885403248962(10)S06191-F
• Combination Product (y/n): N
• PMA/PMN Number: K792669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 23 YR