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	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
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.Furthermore, the customer confirmed that the newborn baby was poked four times to obtain a tracing.
Additional Manufacturer Narrative
The customer confirmed that the device will not be returned for further evaluation; therefore a definitive root cause could not be determined and corrective or preventive action is not indicated at this time.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
Result of investigation:the suspect device is not available for return and no photo sample is available for evaluation.However, a device history record review was performed and each lot tested 100% in black box machine.The revisions were performed according to the work instruction (b)(4) spring height and every characteristics were according to the specification.

• Brand Name: VITAL SIGNS¿ FETAL SPIRAL ELECTRODE FOR COROMETRICS
• Common Device Name: ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): PRECISION CONCEPTS COSTA RICA SA; saret free zone building d3; p.o. box 74-4002; alajuela, ; CS
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 13982901
• Report Number: 3003678543-2022-00002
• Device Sequence Number: 20341511
• Product Code: HGP
• UDI-Device Identifier: 10190752142176
• UDI-Public: (01)10190752142176(10)S23211-H
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K792669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: S23211-H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown