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

Model Number CABLE, FETAL SCALP ELECTRODE, ROUND

Device Problem Connection Problem (2900)

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

Event Date 11/14/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 307724378
• Report Number: 3010838917-2022-00031
• Device Sequence Number: 1
• Product Code: IKD
• UDI-Device Identifier: 10190752178922
• UDI-Public: (01)10190752178922
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1