Kendall 31424785 (UDI 20884527005021)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884527005021), received between Jun 14, 2019 and Feb 24, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Sensing 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THEY WERE USING NEOMED PRE-WIRED LEADS (SIN #(B)(4)) AND WERE ASKED TO CONVERT TO SIN # (B)(4) (CARDINAL HEALTH ITEM CODE 31424785) FOR CONTRACT COMPLIANCE AND SAVINGS. SIN # (B)(4) IS USED OUTSIDE OF THE NICU WITHOUT ISSUE. THE NICU HAS BEEN USING SIN # (B)(4) SINCE (B)(6) 2020. THE NICU MANAGER IS REPORTING SEVERAL COMPLAINTS SIMILAR TO THE FOLLOWING FROM A NICU CHARGE RN: THE NEW ELECTRODES ARE VERY FRUSTRATING TO WORK WITH. THEY DO NOT STAY ON AND WHEN THEY ARE ON, THEY ARE USUALLY READING ARRHYTHMIA. THEY ARE USING SO MANY MORE BECAUSE OF THESE ISSUES THAT THEY DOUBT ANY PROJECTED SAVINGS WILL BE REALIZED. THEY ARE AFRAID THAT THEY ARE CONTRIBUTING TO THE ALARM FATIGUE THAT COULD CAUSE SAFETY ISSUES IN THE UNIT AS WELL. THEY HAVE HEARD NOTHING BUT COMPLAINTS OVER THE WEEKEND. THE NICU HAS CONVERTED BACK TO THE PREVIOUS NEOMED PRODUCT SIN # (B)(4). ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT EACH TIME THE ELECTRODES HAVE READ ARRHYTHMIA, THE SIGNAL HAS BEEN FALSE/INACCURATE. IT IS NOT KNOWN EXACTLY HOW MANY PATIENTS THIS ISSUE HAS OCCURRED WITH BUT ON ANY GIVEN DAY THEY HAD AT LEAST 2-3 PATIENTS WITH ALARMING ISSUES AND HAD TO VERIFY A

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 11372622 ↗
• MalfunctionJun 14, 2019Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER REPORTED THE ELECTRODES OFTEN COME OFF AND DO NOT STAY IN PLACE. THEY NEED TO BE REPLACED OFTEN. THIS PROBLEM CAUSES BAD CAPTURE OF THE HEART AND/OR RESPIRATORY RHYTHM AS WELL AS FALSE READING OR ALARM RESULTS. ANECDOTALLY, THE CUSTOMER REPORTED THAT THIS EVENT OCCURRED ON NUMEROUS INSTANCES, BUT IS UNABLE TO QUANTIFY AN EXACT AMOUNT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8700156 ↗