MAUDE Adverse Event Report: VYAIRE MEDICAL INC. 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 Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical was unable to verify the customer's reported issue.The sample device and the photo are not available for evaluation.Therefore, the root cause of failure could not be determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported to vyaire medical that the 7000aao vital signs¿ fetal spiral electrode for corometrics is defective.The physician noted and she had to pull this through the uterus attached to the fetal scalp and was unable to remove it prior to the surgery.During labor, she had placed a second one, and referred to the one she could not remove as the ""extra fse"".At this time, there is no information regarding patient harm associated with the reported event.There is no information regarding remedial action taken by the healthcare facility however, it was removed after delivery though it is unclear as to who removed it based on the documentation.

• Brand Name: VITAL SIGNS FETAL SPIRAL ELECTRODE FOR COROMETRICS
• Common Device Name: ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 12283482
• Report Number: 3003678543-2021-00001
• Device Sequence Number: 17278750
• Product Code: HGP
• UDI-Device Identifier: 10885403248962
• UDI-Public: (01)10885403248962(17)20210901(10)S13191-F
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2021

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: S13191-F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 DA