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

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/05/2021

Event Type  malfunction  

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 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
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): TECHNICAL SERVICES FOR ELECTRONICS; 2f no.21 chien kand rd.,; chung ho city taipei, K9805 82; TW K980582
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12409717
• MDR Text Key: 273801973
• Report Number: 3008483389-2021-00001
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 10885403255991
• UDI-Public: (01)10885403255991
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: No
• 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