MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS¿ FETAL SPIRAL ELECTRODE CABLE FOR COROMETRICS, RECTANGULAR CONNECTOR; ELECTROCARDIOGRAPHIC LEAD SET, REUSABLE

Model Number	VITAL SIGNS¿ FETAL SPIRAL ELECTRODE CABLE FOR COROMETRICS, RECTANGULAR CONNECTOR
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the scalp electrode was coated in blood and worn out to the point where the wires are already exposed.This is a patient accessory and was removed from the patient area.The customer confirmed that there is no patient impact.
Additional Manufacturer Narrative
The sample has been discarded.Therefore, no root cause could be determined.

• Brand Name: VITAL SIGNS¿ FETAL SPIRAL ELECTRODE CABLE FOR COROMETRICS, RECTANGULAR CONNECTOR
• Common Device Name: ELECTROCARDIOGRAPHIC LEAD SET, REUSABLE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): CARLISLE MEDICAL TECHNOLOGIES; carlisle medical technologies; dengwu village, qiaotou town; dongguan, 52353 3; CH 523533
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 14529325
• Report Number: 3013596024-2022-00004
• Device Sequence Number: 20458663
• Product Code: IKD
• UDI-Device Identifier: 10190752178939
• UDI-Public: (01)10190752178939
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K993751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VITAL SIGNS¿ FETAL SPIRAL ELECTRODE CABLE FOR COROMETRICS, RECTANGULAR CONNECTOR
• Device Catalogue Number: 1591AAO
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 05/27/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown