MAUDE Adverse Event Report: VYAIRE MEDICAL INC. MULTI-LINK ECG CARE CABLE, 12-LEAD, AHA, 3.6M / 12FT; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number	MULTI-LINK¿ ECG CARE CABLE, 12-LEAD, AHA, 3.6M / 12FT
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).There was no photo, lot number, and no product was returned for evaluation; therefore a definitive root cause could not be determined and corrective or preventive action is not indicated at this time.This complaint will be included in the ongoing complaint trending analysis.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that the ecg machine was alarming an asystole continuously even after the 2017006-001 multi-link¿ ecg care cable, 12-lead, aha, 3.6m / 12 ft cables are unplugged.This device is designed for monitoring and does not provide medication.Based on the available information, the customer did not report any patient or user harm as a result of the issue described.

• Brand Name: MULTI-LINK ECG CARE CABLE, 12-LEAD, AHA, 3.6M / 12FT
• Common Device Name: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 12409717
• Report Number: 3008483389-2021-00001
• Device Sequence Number: 11746180
• Product Code: DSA
• UDI-Device Identifier: 10885403255991
• UDI-Public: (01)10885403255991
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K980582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MULTI-LINK¿ ECG CARE CABLE, 12-LEAD, AHA, 3.6M / 12FT
• Device Catalogue Number: 2017006-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1