MAUDE Adverse Event Report: VYAIRE MEDICAL OY LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE; ELECTRODE, ELECTROCARDIOGRAPH

Model Number LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE

Device Problem Connection Problem (2900)

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

Event Date 10/28/2022

Event Type  Injury  

Event Description

The customer reported to vyaire medical that the leg attachment pad for corometrics fetal scalp electrode cable was not firmly attached to the cable during patient use.The device is easily detached, which results in a loss of fetal heart rate signal.The customer had to tape the cable to the attach pad prior to adhering it to the patients leg and reinforcing with more tape.Furthermore, the customer confirmed no harm was done to the patient.

Manufacturer Narrative

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.

Manufacturer Narrative

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.Actual suspect sample was not returned, but investigation was done using a different lot number with the same complaint returned from the user.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: LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2; etela-suomen laani; helsinki 00510 ; FI 00510
• Manufacturer (Section G): GRAPHIC CONTROLS ACQUISITION CORP.; 400 exchange st; buffalo NY 14204
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 15870292
• MDR Text Key: 304367691
• Report Number: 3010838917-2022-00029
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: Yes
• 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: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention