MAUDE Adverse Event Report: VYAIRE MEDICAL MULTI-LINK ECG LEADWIRE, GROUPED SET, 5-LEAD, GRABBER, AHA, 74 CM/29 IN; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number MULTI-LINK¿ ECG LEADWIRE, GROUPED SET, 5-LEAD, GRABBER, AHA, 74 CM/29 IN

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

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

Event Date 02/25/2021

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 multi-link¿ ecg leadwire, grouped set, 5-lead, grabber, aha, 74 cm/29 in provided an incorrect reading of the heart rate.In the monitor, the heart rate was 30 to 40 beats per minutes, while on the doctor manual check of the heart rate is around 60 beats per minute.There was no harm noted as the monitor was replaced.

Manufacturer Narrative

Device evaluation: g3, g6, h2, h3, h6, and h10.Result of investigation: the device history record (dhr) review did not show any deviations to manufacturer specifications.For functionality failure, it is imperative to receive a sample to duplicate the failure as described.

• Brand Name: MULTI-LINK ECG LEADWIRE, GROUPED SET, 5-LEAD, GRABBER, AHA, 74 CM/29 IN
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11544425
• MDR Text Key: 244386814
• Report Number: 3013596024-2021-00002
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 10885403257049
• UDI-Public: (01)10885403257049(10)200116T
• Combination Product (y/n): N
• PMA/PMN Number: K980582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MULTI-LINK¿ ECG LEADWIRE, GROUPED SET, 5-LEAD, GRABBER, AHA, 74 CM/29 IN
• Device Catalogue Number: 412681-001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention