Kendall 33507Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884527021475), received between Mar 23, 2021 and Jun 29, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE ICU MONITOR READ CRAZY RHYTHMS (FALSE/INACCURATE READING, ASYSTOLE AND ARTIFACT) ON A PATIENT WHEN USING THE DEVICE DURING A TRIAL DURING THE WEEK OF (B)(6) 2022. THE PATIENT HAD EXTERNAL PACING WIRES FROM CARDIAC SURGERY THAT CAME FROM OPERATING ROOM. THE WIRES ARE SHOWING AND CONNECT TO A SMALL BOX FOR PACING. WHEN HOOKED BACK UP TO THE REUSABLE, THEY DID NOT HAVE FALSE TRACINGS LIKE ASYSTOLE OR ARTIFACT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14854330 ↗
• MalfunctionJun 1, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE ICU MONITOR READ CRAZY RHYTHMS WHEN USING THE DEVICE. THE CUSTOMER STATED THEY CHANGED OUT THE PRODUCTS WITHOUT RESOLUTION. WHEN THEY PUT THE PATIENT BACK ON THE REUSABLE LEAD, THE ISSUE WAS RESOLVED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 STATED THAT THE PRODUCTS PROVIDED A FALSE/INACCURATE READING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14566568 ↗
• MalfunctionJun 1, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE ICU MONITOR READ CRAZY RHYTHMS WHEN USING THE DEVICE. THE CUSTOMER STATED THEY CHANGED OUT THE PRODUCTS WITHOUT RESOLUTION. WHEN THEY PUT THE PATIENT BACK ON THE REUSABLE LEAD, THE ISSUE WAS RESOLVED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 STATED THAT THE PRODUCTS PROVIDED A FALSE/INACCURATE READING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14566553 ↗
• MalfunctionApr 9, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT ONE PATIENT WAS SHOWING A HEART RATE IN THE 30'S. THE NURSE ALMOST PUSHED ATROPIN AND ANOTHER NURSE STATED SHE CHECKED THE LEADWIRES AND "MANIPULATED" THE PINK ADAPTER CONNECTED TO THE MONITOR AND THE PATIENT'S RHYTHM THEN STARTED TO SHOW IT WAS 88. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640996 ↗
• MalfunctionMar 23, 2021Overheating of Device; Overheating of Device

  THE CUSTOMER REPORTED THAT THE ADAPTER MELTED. THERE WERE NO ISSUES OBSERVED WITH ANY OTHER PRODUCTS BEING USED WITH THE ADAPTER AT THE TIME. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11557827 ↗