Kendall 31424785 (UDI 20192253017387)Recalls & reported problems
Cardinal Health 200, LLC · PuppyDog 1041PTS Neonatal, Radiolucent, Monitoring Clear Tape electrode ( 3/PK)-Square · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20192253017387), received between Feb 25, 2025 and Feb 25, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Pacing Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Pacing Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2025Pacing Problem; Pacing Problem
THE CUSTOMER REPORTED THEIR NICU HAS HAD TO SWITCH BACK TO THEIR ORIGINAL NEOTECH ITEM, #N306 DUE TO THE FOLLOWING COMPLAINT RECEIVED BACK IN DECEMBER: THE RECENT ELECTRODE CONVERSION WAS NOT A 1:1 CONVERSION. THEY NEED TO KEEP THE MICRO NEOLEADS (REF N306). IT WAS CONVERTED TO LIMB LEADS (REF EP30016) AND THESE ARE NOT EQUIVALENT. THE REF FOR THE OTHER LEADS THAT THEY ARE HAVING ISSUES WITH IS 31424785, AND THESE ARE CAUSING THE MONITORS TO PICK UP INACCURATELY READING THE HEART RATE AS THE RESPIRATORY RATE, WHICH IN TURN CAN BE A CLINICAL CAUSE OF CONCERN IN THEIR POPULATION THAT COULD CAUSE FURTHER TESTING/WORKUP, AND/OR A DELAY IN DISCHARGE, ETC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21465327 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.