MAUDE Adverse Event Report: VYAIRE MEDICAL ECG LEADWIRE, DIN, RADIOLUCENT, 5-LEAD, GRABBER, AHA, 150 CM/59 IN; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number	ECG LEADWIRE, DIN, RADIOLUCENT, 5-LEAD, GRABBER, AHA, 150 CM/59 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	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not 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 ekg signal of ecg leadwire, din, radiolucent, 5-lead, grabber, aha, 150 cm/59 in is very fuzzy.The lead 2 show artifact, tachycardia and unclear ekg rhythm even if the patient is not moving.At this time, there is no information regarding patient harm associated with the reported event.

• Brand Name: ECG LEADWIRE, DIN, RADIOLUCENT, 5-LEAD, GRABBER, AHA, 150 CM/59 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: 11614729
• Report Number: 3013596024-2021-00003
• Device Sequence Number: 16893706
• Product Code: DSA
• UDI-Device Identifier: 10885403256936
• UDI-Public: (01)10885403256936
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2021

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: ECG LEADWIRE, DIN, RADIOLUCENT, 5-LEAD, GRABBER, AHA, 150 CM/59 IN
• Device Catalogue Number: 403751-009
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1