MAUDE Adverse Event Report: VYAIRE MEDICAL OY VITAL SIGNS¿ LEG ATTACHMENT PAD; ELECTROCARDIOGRAPHIC ELECTRODE, SINGLE-USE

Model Number LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE

Device Problem Fitting Problem (2183)

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

Event Date 10/27/2022

Event Type  malfunction  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It was reported to vyaire medical that the connection was not good on 2464aao-20 - leg attachment pad for corometrics fetal scalp electrode cable.Also, the device keep coming apart on patient.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

Device evaluation: g3, g6, h2, h3, h6 and h10.Result of investigation: the device history paperwork was reviewed for all lots, specifically reviewing the foam and snap lots to determine what lots were used and when.There were multiple lots of both the snaps and foam used during production.There were samples returned from lot 314665.Visual inspection reveals some of the snaps were broken.The wire connector was mated with the returned samples.The connector/snap mating found that some of the snaps were difficult to press into the connector.However, no electrodes disconnected from the device.Also, peel testing could not be performed on the foam of the returned samples as the strip label was impacting the adhesion results, skewing them to a much higher result.Therefore, the reported failure could not be duplicated/reproduced, and the root cause could not be determined.Though, the broken snap may contribute to the connector and electrode mating issue.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: VITAL SIGNS¿ LEG ATTACHMENT PAD
• Type of Device: ELECTROCARDIOGRAPHIC ELECTRODE, SINGLE-USE
• 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: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 15844022
• MDR Text Key: 307778979
• Report Number: 3010838917-2022-00028
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 10190752188181
• UDI-Public: (01)10190752188181(10)314665
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• 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: 314665
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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