MAUDE Adverse Event Report: VYAIRE MEDICAL OY VITAL SIGNS¿; FETAL SPIRAL ELECTRODE FOR COROMETRICS

Model Number	7000AAO
Medical Device Problem Codes	Fitting Problem (2183); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that when the provider was attempting to place a fetal scalp electrode on a trial of labor after a cesarean (tolac) patient who was laboring naturally without an epidural, the 7000aao-electrodes, fetal scalp (fse), 50/case would not stay snapped into place or stuck to the patient's leg and therefore would not read.A registered nurse (rn) at the desk retrieved another fetal scalp electrode (fse) and cord from another room that was placed without incident.The patient's current status is still unknown.
Additional Manufacturer Narrative
H11: after further review of this complaint.Vyaire medical found out that this complaint is only a duplicate of the original report received last 14-sept-2023.Therefore, this is deemed as a non quality complaint to vyaire medical.Kindly refer to the vyaire reference number of the original complaint: (b)(4) under medwatch manufacturer report number: 3010838917-2023-00090.Please disregard and void the report submitted from vyaire reference number: (b)(4) under manufacturer report number: 3010838917-2023-00094.
Additional Manufacturer Narrative
H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H11: after further review of this complaint.Vyaire medical found out that this complaint is only a duplicate of the original report received last 14-sept-2023.Therefore, this is deemed as a non quality complaint to vyaire medical.Kindly refer to the vyaire reference number of the original complaint: (b)(4) under medwatch manufacturer report number: 3010838917-2023-00090.Please disregard and void the report submitted from vyaire reference number: (b)(4) under manufacturer report number.Udi related data quality updates only updated brand name, device description and remove 510(k) number.Took out the hyphen in the udi lot number this is a duplicate reporting to 3010838917-2023-00090.
Event or Problem Description
It was reported to vyaire medical that when the provider was attempting to place a fetal scalp electrode on a trial of labor after a cesarean (tolac) patient who was laboring naturally without an epidural, the 7000aao-electrodes, fetal scalp (fse), 50/case would not stay snapped into place or stuck to the patient's leg and therefore would not read.A registered nurse (rn) at the desk retrieved another fetal scalp electrode (fse) and cord from another room that was placed without incident.The patient's current status is still unknown.

• Brand Name: VITAL SIGNS¿
• Common Device Name: FETAL SPIRAL ELECTRODE FOR COROMETRICS
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2; helsinki etela-suomen laani; helsinki etela-suomen laani, fl FIN-0 0510; FI FIN-00510
• Manufacturer (Section G): PRECISION CONCEPTS COSTA RICA SA; saret free zone building d3; p.o. box 74-4002; alajuela, costa rica ; CS
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18361329
• Report Number: 3010838917-2023-00094
• Device Sequence Number: 7856466
• Product Code: HGP
• UDI-Device Identifier: 10190752142176
• UDI-Public: (01)10190752142176(10)S4122H
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2024

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: 7000AAO
• Device Catalogue Number: 7000AAO
• Device Lot Number: S4122-H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 01/29/2024; 11/21/2023
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 02/09/2024; 10/09/2024
• 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; Other
• Patient Sex: Unknown