ECG Cables and Leadsets CBL 5 Lead Set Snap IEC, ICURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838010833), received between Mar 18, 2019 and Mar 18, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2019Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER STATED THAT THE MRX IS FAILING OPERATIONAL CHECKS DURING THE "LEADS ECG CHECK". THE DEVICE WAS IN USE AND THERE WAS NO REPORTED PATIENT/USER IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8429633 ↗