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

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

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

Event Date 03/10/2021

Event Type  malfunction  

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 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
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): CARLISLE MEDICAL TECHNOLOGIES (DONGGUAN) CO., LTD; no.2 xinhu industrial park,; dengwu village, qiaotou town; dongguan, 52353 3; CH 523533
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 11614729
• MDR Text Key: 243923132
• Report Number: 3013596024-2021-00003
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 10885403256936
• UDI-Public: (01)10885403256936
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1