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

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

Event Type  malfunction  

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 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
• Type of Device: ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 12283482
• MDR Text Key: 280958942
• Report Number: 3003678543-2021-00001
• Device Sequence Number: 1
• Product Code: HGP
• UDI-Device Identifier: 10885403248962
• UDI-Public: (01)10885403248962(17)20210901(10)S13191-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
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• 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: S13191-F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 DA