MAUDE Adverse Event Report: VYAIRE MEDICAL OY VITAL SIGNS¿ LEG ATTACHMENT PAD; ELECTRODE, ELECTROCARDIOGRAPH

Model Number LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE

Device Problem Disconnection (1171)

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

Event Date 01/09/2024

Event Type  malfunction  

Event Description

The customer reported to vyaire medical that the leg attachment pad snaps connection to the adhesive leg plate is not secure.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.On follow-up, the customer confirmed that the sample was thrown away after patient use.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : product discarded.

Manufacturer Narrative

The device was not returned for evaluation.Analysis found that during the in-process check, the run had no noted non-conformances.One of the things verified during each in-process check is the leg pad's dimensional compatibility with the leg plate.This check is performed to ensure proper connection with the electrode snap and leg plate.The checks throughout the lot run showed the product was conforming.Vyaire has confirmed that the life cycle of the connector wire is 300 cycles, and it is possible that older connectors that are at the end of their lives are out in the field.

• Brand Name: VITAL SIGNS¿ LEG ATTACHMENT PAD
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2 helsinki ete; la-suomen laani, finland fin; helsinki ; FI
• Manufacturer (Section G): GRAPHIC CONTROLS ACQUISITION CORP.; 400 exchange st; buffalo NY
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18636984
• MDR Text Key: 334518577
• Report Number: 3010838917-2024-00099
• Device Sequence Number: 1
• Product Code: DRX
• 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,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE
• Device Catalogue Number: 2464AAO-20
• Device Lot Number: 337566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1