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
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	02/25/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11544425
• Report Number: 3013596024-2021-00002
• Device Sequence Number: 11686753
• Product Code: DSA
• UDI-Device Identifier: 10885403257049
• UDI-Public: (01)10885403257049(10)200116T
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K980582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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 LEADWIRE, GROUPED SET, 5-LEAD, GRABBER, AHA, 74 CM/29 IN
• Device Catalogue Number: 412681-001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention