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

Model Number	7000AAO
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to vyaire medical that they are attempting to place fetal spiral electrode for corometrics on a tolac (trial of labor after cesarean delivery) patient who was laboring naturally and the product would not stay snapped into place nor would it stick yo the patient's leg.Furthermore, the customer confirmed no harm was done to the patient.
Additional Manufacturer Narrative
H3: 81 other - the sample has been discarded.Therefore, no root cause could be determined.The device history record of the lot number will be reviewed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
Additional information: g3, g6, h2, h3, h6 and h10.Result of investigation:vyaire medical was unable to confirm the reported issue.There was no sample returned for evaluation.Device history record was reviewed and no issues related to the reported issue found.The retained samples was reviewed, tested, and no any other issues was found related with the said issue.
Additional Manufacturer Narrative
H3: 81 other - the sample has been discarded.Therefore, no root cause could be determined.The device history record of the lot number will be reviewed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Additional information: g3, g6, h2, h3, h6 and h10.Result of investigation: vyaire medical was unable to confirm the reported issue.There was no sample returned for evaluation.Device history record was reviewed and no issues related to the reported issue found.The retained samples was reviewed, tested, and no other issues was found related with the said issue.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.
Event or Problem Description
The customer reported to vyaire medical that they are attempting to place fetal spiral electrode for corometrics on a tolac (trial of labor after cesarean delivery) patient who was laboring naturally and the product would not stay snapped into place nor would it stick yo the patient's leg.Furthermore, the customer confirmed no harm was done to the patient.

• Brand Name: VITAL SIGNS¿
• Common Device Name: FETAL SPIRAL ELECTRODE FOR COROMETRICS
• Manufacturer (Section D): VYAIRE MEDICAL OY,; kuortaneenkatu 2 helsinki; etela-suomen laani; etela-suomen laani, helsinki 00510 ; FI 00510
• Manufacturer (Section G): PRECISION CONCEPTS COSTA RICA SA; saret free zone building d3; p.o. box 74-4002; alajuela, costa rica CS ; CS CS
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 17927783
• Report Number: 3010838917-2023-00090
• Device Sequence Number: 20446822
• 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: 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?: No
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/18/2024; 09/14/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 01/23/2024; 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: Other
• Patient Sex: Unknown