MAUDE Adverse Event Report: VYAIRE MEDICAL OY CABLE, FETAL SCALP ELECTRODE, ROUND; CABLE, ELECTRODE

Model Number	CABLE, FETAL SCALP ELECTRODE, ROUND
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire file identification:com-(b)(4).Device evaluated by mfr: at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Device not returned yet.
Event or Problem Description
It was reported to vyaire medical that a connectivity problem while connecting to the corometrics monitor prevents the fetal scalpel electrode from receiving tracing.At this time, there is no information regarding patient involvement associated with the reported event.

• Brand Name: CABLE, FETAL SCALP ELECTRODE, ROUND
• Common Device Name: CABLE, ELECTRODE
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2 helsinki ete; la-suomen laani, finland fin; helsinki ; FI
• Manufacturer (Section G): CARLISLE MEDICAL TECHNOLOGIES (DONGGUAN) CO., LTD; no.2 xinhu industrial park, de; ngwu village, qiaotou town; dongguan 52353 3; CH 523533
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 15893698
• Report Number: 3010838917-2022-00031
• Device Sequence Number: 12064426
• Product Code: IKD
• UDI-Device Identifier: 10190752178922
• UDI-Public: (01)10190752178922
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2022

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: CABLE, FETAL SCALP ELECTRODE, ROUND
• Device Catalogue Number: 1590AAO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 12/01/2022
• 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
• Patient Sex: Unknown